Draeger Medical Systems, Inc.
Telford, PA, US
DRAEGER MEDICAL SYSTEMS, INC. appears in FDA device records in Telford, PA. FDA records list 48 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 34 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Draeger Medical Systems, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Draegar Medical Systems, Inc.enforcement report, recall
510(k) clearance history
FDA records hold 48 510(k) clearances for Draeger Medical Systems, Inc. between 2003 and 2025. The busiest year on record is 2004, with 8. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 3 |
| 2004 | 8 |
| 2005 | 6 |
| 2006 | 5 |
| 2007 | 2 |
| 2008 | 2 |
| 2010 | 1 |
| 2011 | 2 |
| 2012 | 3 |
| 2013 | 1 |
| 2014 | 3 |
| 2015 | 1 |
| 2018 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 2 |
| 2024 | 2 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243606 | Babyroo TN300 | FMT | Substantially Equivalent | |
| K240312 | Infinity CentralStation Wide | MHX | Substantially Equivalent | |
| K233834 | Infinity Gateway Suite | MSX | Substantially Equivalent | |
| K231477 | Infinity CentralStation Wide, Infinity M300, Infinity M300+ | MHX | Substantially Equivalent | |
| K230278 | Babyroo TN300 | FMT | Substantially Equivalent | |
| K203579 | Infinity Gateway Suite | MSX | Substantially Equivalent | |
| K203088 | Infinity Acute Care System (IACS) Monitoring System | MHX | Substantially Equivalent | |
| K201764 | Infinity Acute Care System (IACS) Monitoring Solution | MHX | Substantially Equivalent | |
| K200859 | Infinity M300 | MHX | Substantially Equivalent | |
| K182977 | Isolette 8000 Plus | FMZ | Substantially Equivalent | |
| K172656 | BiliLux | LBI | Substantially Equivalent | |
| K151860 | Infinity CentralStation Wide | MHX | Substantially Equivalent | |
| K141756 | INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION | MSX | Substantially Equivalent | |
| K133175 | DRAEGER JAUNDICE METER JM-105 | MQM | Substantially Equivalent | |
| K141565 | GLOBE-TROTTER GT5400 | FPL | Substantially Equivalent | |
| K130711 | INFINITY CENTRALSTATION WITH INFINITY M300 | MHX | Substantially Equivalent | |
| K120642 | RESUSCITAIRE WITH AUTOBREATH | FMT | Substantially Equivalent | |
| K113798 | INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET | MHX | Substantially Equivalent | |
| K113206 | NANOBLUTM 500 | LBI | Substantially Equivalent | |
| K103625 | OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE | CBK | Substantially Equivalent | |
| K102968 | INFINITY CNAP SMARTPOD | DXN | Substantially Equivalent | |
| K093788 | INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION | MHX | Substantially Equivalent | |
| K082888 | INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997 | DQA | Substantially Equivalent | |
| K073113 | INFINITY PICCO POD, MODEL MS16734 | DXG | Substantially Equivalent | |
| K070566 | INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL | MHX | Substantially Equivalent | |
| K061379 | INFINITY TELESMART TELEMETRY SYSTEM | MHX | Substantially Equivalent | |
| K061329 | INFINITY MASIMO SET SP02 POD | DQA | Substantially Equivalent | |
| K060223 | INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM | MHX | Substantially Equivalent | |
| K060039 | INFINITY DELTA AND KAPPA SERIES MONITORS WITH VF6 MODIFICATIONS | MHX | Substantially Equivalent | |
| K060254 | MODIFICATION TO INFINITY EXPLORER | MSX | Substantially Equivalent | |
| K053484 | INFINITY GAMMA / GAMMAXL, INFINITY VISTA | MHX | Substantially Equivalent | |
| K051658 | INFINITY ALPHA | MHX | Substantially Equivalent | |
| K051628 | INFINITY MONITORS WITH SCIO MODIFICATIONS | MHX | Substantially Equivalent | |
| K050974 | DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS | DRQ | Substantially Equivalent | |
| K043439 | INFINITY MODULAR MONITORS WITH VF5 MODIFICATIONS (DELTA/KAPPA/DELTA XL/VISTA XL/GAMMA X XL AND SC 7000/8000/9000XL | MHX | Substantially Equivalent | |
| K042904 | INFINITY KAPPA XLT | MHX | Substantially Equivalent | |
| K043549 | INFINITY GATEWAY SUITE, VF4 | MHX | Substantially Equivalent | |
| K042656 | INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5 | MHX | Substantially Equivalent | |
| K042003 | INFINITY TRIDENT NMT POD | KOI | Substantially Equivalent | |
| K033957 | INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA XL, KAPPA, SC 8000, SC 7000, SC 9000XL | MHX | Substantially Equivalent | |
| K041087 | INFINITY GAMMA | MHX | Substantially Equivalent | |
| K040945 | MODIFICATION TO INFINITY EXPLORER | MSX | Substantially Equivalent | |
| K040188 | INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE | NHP | Substantially Equivalent | |
| K033694 | INFINITY MODULAR MONITORS VF4 MODIFICATIONS | MHX | Substantially Equivalent | |
| K033807 | INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER | DRQ | Substantially Equivalent | |
| K033600 | INFINITY GAMMAXL | MHX | Substantially Equivalent | |
| K032537 | DRAEGER MICRO2+ AND MASIMO MINISAT | DQA | Substantially Equivalent | |
| K033305 | INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM | DSI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2510954 | 2510954 | DRAEGER MEDICAL SYSTEMS, INC. | 3135 QUARRY RD., Telford, PA 18969 US | 2026 | |
| 3005783425 | 3005783425 | DRAEGER MEDICAL SYSTEMS, INC. | 6 TECH DRIVE, ANDOVER, MA 01810 US | 2026 | and 31 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DRQAmplifier And Signal Conditioner, Transducer Signal
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- NHOAnalyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
- CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
- CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
- NHQAnalyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
- CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- NHPAnalyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
- MQMBilirubin (Total And Unbound) In The Neonate Test System
- ORTBurst Suppression Detection Software For Electroencephalograph
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- CATCannula, Nasal, Oxygen
- DQECatheter, Oximeter, Fiber-Optic
- DSKComputer, Blood-Pressure
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- BZAConnector, Airway (Extension)
- FLLContinuous Measurement Thermometer
- DSIDetector And Alarm, Arrhythmia
- DPSElectrocardiograph
- DRXElectrode, Electrocardiograph
- BSZGas-Machine, Anesthesia
- FMZIncubator, Neonatal
- FPLIncubator, Neonatal Transport
- OLWIndex-Generating Electroencephalograph Software
- FLSMonitor, Apnea, Facility Use
- BZQMonitor, Breathing Frequency
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- MLDMonitor, St Segment With Alarm
- OLTNon-Normalizing Quantitative Electroencephalograph Software
- DQAOximeter
- DSBPlethysmograph, Impedance
- DSFRecorder, Paper Chart
- OMCReduced- Montage Standard Electroencephalograph
- BZKSpirometer, Monitoring (W/Wo Alarm)
- IPFStimulator, Muscle, Powered
- KOIStimulator, Nerve, Peripheral, Electric
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- MSXSystem, Network And Communication, Physiological Monitors
- BXPTransducer, Gas Flow
- LBIUnit, Neonatal Phototherapy
- CBKVentilator, Continuous, Facility Use
- BTLVentilator, Emergency, Powered (Resuscitator)
- FMTWarmer, Infant Radiant
Recall records
Showing 25 of 34| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1066-2025 | Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of data from networked patient monitors including the annunciation of visual and audible physiologic parameter alarms at a central monitoring workstation. | Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mode which can lead to delayed treatment to the patient. | Class II | Open, Classified | |
| Z-2189-2024 | Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23 | Device is not in full compliance to Type CF requirements of IEC 60601-1 and IEC 60601-2-34 standards. Therefore, there is a potential risk of electric shock. Health consequences may include electrical shock, burns, and cardiac arrhythmia. | Class II | Open, Classified | |
| Z-1992-2023 | Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1, RW82-1C, RW82-1D, WBR82-1 and WBR82-1C] | The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values. | Class II | Open, Classified | |
| Z-1472-2023 | Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network, | The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition, ECG waveforms with unusually narrow and/or high frequency QRS may be displayed or printed with QRS amplitudes intermittently lower than actual. | Class II | Open, Classified | |
| Z-1471-2023 | Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower | The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition, ECG waveforms with unusually narrow and/or high frequency QRS may be displayed or printed with QRS amplitudes intermittently lower than actual. | Class II | Open, Classified | |
| Z-1365-2022 | Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system | The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the working pressure of the system. | Class II | Open, Classified | |
| Z-1012-2022 | Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices. | Software issue resulting in temporary loss of central monitoring functionality. | Class II | Open, Classified | |
| Z-1104-2021 | Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals. | The Infinity M540 patient monitor may randomly reboot due to an error to correctly transmit and read the header data of files in the memory of the device. Under this situation, the device will try to reboot to mitigate the error. The device will be available again for use within 30 seconds. If this error continues and the M540 reboots three times in a time span of 10 minutes, it will enter a fail-state. A fail-state will annunciate itself with a continuous sound to alert the user. The M540 will reset to factory default and the user can manually configure and readmit the patient to continue patient monitoring. | Class II | Open, Classified | |
| Z-0372-2020 | Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301 | The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering. | Class II | Open, Classified | |
| Z-0258-2020 | The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372. | Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network. | Class II | Open, Classified | |
| Z-0975-2019 | Omega Systems These devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition. | The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose communication. | Class II | Open, Classified | |
| Z-0974-2019 | Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcp02, which for the neonatal population, is to only be used when the patient is not under gas anesthesia.-Omega and Omega S are intended to be used on adult, pediatric, and neonatal populations. | The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose communication. | Class II | Open, Classified | |
| Z-2047-2018 | Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements. The Jaundice Meter is not intended for home use. The Jaundice Meter may only be used at the sternum measurement site for Physician s office applications. | Users have misinterpreted the display for out of range measurement indicated by the blinking "-0-" to mean a zero measurement | Class I | Terminated | |
| Z-2046-2018 | Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements. The Jaundice Meter is not intended for home use. The Jaundice Meter may only be used at the sternum measurement site for Physician s office applications | Users have misinterpreted the display for out of range measurement indicated by the blinking" ---" to mean a zero measurement. | Class I | Terminated | |
| Z-1813-2018 | Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751. Multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals. The lACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network. The M540 is intended to monitor one patient at a time. | Software anomaly resulting in the loss of patient settings and stored patient data. | Class II | Terminated | |
| Z-1382-2018 | Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751 Multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professsionals. The lACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network. The M540 is intended to monitor one patient at a time. | The invasive pressure visual and audible alarms may not activate. | Class II | Terminated | |
| Z-0942-2018 | INFINITY DUAL HEMO MCable Pod | Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Drger Infinity Acute Care System, may permit liquid ingress inconsistent with their IPX4 rating, which could potentially result in an incorrect measured value of invasive blood pressure. | Class II | Terminated | |
| Z-2734-2017 | Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722 | Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alarms on the Cockpit and Central Station. | Class II | Terminated | |
| Z-1774-2017 | Kappa, Catalog Number: MS18853 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Catalog Number(s): MS18597/MS18596/MS18853. Product Usage: The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patients medical condition. The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcpO2, which for the neonatal population, is to only be used when the patient is not under gas anesthesia. For combination with Scio gas module: Scio gas module samples breathing gases from adults and pediatrics. The gas module continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the In-finity monitors. | It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit. | Class II | Terminated | |
| Z-1773-2017 | Delta XL, Catalog Number: MS18596 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Product Usage: The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patients medical condition. The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcpO2, which for the neonatal population, is to only be used when the patient is not under gas anesthesia. For combination with Scio gas module: Scio gas module samples breathing gases from adults and pediatrics. The gas module continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the In-finity monitors. | It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit. | Class II | Terminated | |
| Z-1772-2017 | Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Product Usage: The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patients medical condition. The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcpO2, which for the neonatal population, is to only be used when the patient is not under gas anesthesia. For combination with Scio gas module: Scio gas module samples breathing gases from adults and pediatrics. The gas module continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the In-finity monitors. | It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit. | Class II | Terminated | |
| Z-1440-2014 | Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833 | The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted and the device discontinues ventilation, gives an audible alarm and displays the error message Poti unplugged. | Class I | Terminated | |
| Z-1298-2014 | Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ventilators, used for ventilation during short term transport of patients within a hospital. | The battery capacity of the optional PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected. | Class I | Terminated | |
| Z-0714-2014 | Draeger Infinity Acute Care System Monitoring Solution | After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo-natal mode and was subsequently paused, the high grade life threatening SpO2 alarm (red) did not activate when the SpO2 values were decreased to reach the red alarm limit. | Class II | Terminated | |
| Z-1950-2012 | Drager PT 4000 Phototherapy System | A routine internal quality check found that the Drager PT 4000 Phototherapy System is fitted with a 16 Amp rated fuse instead of the specified 1.6 Amp rated fuse. This may mean that the internal fuse would not trip promptly in the event of an internal short-circuit. The possible consequence is the wall outlet circuit breaker would trip first on the device may severely overheat. There have not b | Class II | Terminated |
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