Draeger, Inc.
Telford, PA, US
DRAEGER, INC. appears in FDA device records in Telford, PA. FDA records list 84 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 124 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, 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.
- Draeger Medical, Inc.510(k), enforcement report, recall
510(k) clearance history
Showing 50 of 84FDA records hold 84 510(k) clearances for Draeger, Inc. between 1977 and 2014. The busiest year on record is 1987, with 8. The most recent is 2014, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 5 |
| 1979 | 2 |
| 1980 | 4 |
| 1982 | 2 |
| 1983 | 5 |
| 1984 | 2 |
| 1985 | 4 |
| 1986 | 6 |
| 1987 | 8 |
| 1988 | 3 |
| 1990 | 4 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1995 | 1 |
| 1996 | 1 |
| 1997 | 5 |
| 1998 | 7 |
| 1999 | 1 |
| 2000 | 2 |
| 2001 | 1 |
| 2002 | 3 |
| 2003 | 1 |
| 2004 | 8 |
| 2006 | 1 |
| 2008 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K121886 | SAVINA 300 SAVINA 300, COUNTRY VARIANTS | CBK | Substantially Equivalent | |
| K133886 | PERSEUS A500 | BSZ | Substantially Equivalent | |
| K121999 | GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE | FLL | Substantially Equivalent | |
| K103035 | SMARTPILOT VIEW MODEL MK04500 | BSZ | Substantially Equivalent | |
| K082600 | OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082) | CBK | Substantially Equivalent | |
| K060705 | CARINA HOME | CBK | Substantially Equivalent | |
| K042607 | PRIMUS US | BSZ | Substantially Equivalent | |
| K042419 | FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM | BSZ | Substantially Equivalent | |
| K042276 | D-VAPOR | CAD | Substantially Equivalent | |
| K042086 | FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM | BSZ | Substantially Equivalent | |
| K041622 | MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM | BSZ | Substantially Equivalent | |
| K040847 | MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR | CCK | Substantially Equivalent | |
| K033498 | NARKOMED 6400, MODEL NM6400 | BSZ | Substantially Equivalent | |
| K030624 | MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM | BSZ | Substantially Equivalent | |
| K031400 | FABIUS TIRO ANESTHESIA SYSTEM | BSZ | Substantially Equivalent | |
| K022031 | NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2 | BSZ | Substantially Equivalent | |
| K011404 | FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS | BSZ | Substantially Equivalent | |
| K012139 | VAMOS ANESTHETIC GAS MONITOR | CCK | Substantially Equivalent | |
| K003579 | NARKOMED MRI-2, MODEL NM-MRI-2 | BSZ | Substantially Equivalent | |
| K001488 | NARKOMED MRI , NM-MRI | BSZ | Substantially Equivalent | |
| K993826 | NARKOMED 6000 | MLC | Substantially Equivalent | |
| K983635 | JULIAN ANESTHESIA WORKSTATION, MODEL # JULIAN | BSZ | Substantially Equivalent | |
| K980553 | NARKOMED 6000 MODEL NUMBER NM6000 | BSZ | Substantially Equivalent | |
| K980208 | DIVAN ANESTHESIA VENTILATOR | CBK | Substantially Equivalent | |
| K981773 | DRAGER-VAPOR 19.3 | CAD | Substantially Equivalent | |
| K980886 | BABYTHERM 8000 LDR | FMZ | Substantially Equivalent | |
| K981472 | DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS | CAD | Substantially Equivalent | |
| K973949 | PERIOPERATIVE DATA MANAGEMENT SYSTEM | BSZ | Substantially Equivalent | |
| K974193 | NARKOMED ULTRASONIC FLOW SENSOR | BSZ | Substantially Equivalent | |
| K973051 | DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS | CAD | Substantially Equivalent | |
| K972848 | NARKOMED MRI ANESTHESIA SYSTEM | BSZ | Substantially Equivalent | |
| K971923 | DRAGER-VAPOR 2000 | CAD | Substantially Equivalent | |
| K971425 | NARKOMED M ANESTHESIA SYSTEM (M) | BSZ | Substantially Equivalent | |
| K963994 | NARKOMED GS ANESTHESIA SYSTEM | BSZ | Substantially Equivalent | |
| K953228 | NARKOMED AV2+ ANESTHESIA VENTILATOR | CBK | Substantially Equivalent - Subject to Tracking Reg. | |
| K945463 | PENDANT MOUNT NARKOMED 2C ANESTHESIUA SYSTEM | BSZ | Substantially Equivalent | |
| K930351 | NARKOMED 2C ANESTHESIA SYSTEM | BSZ | Substantially Equivalent | |
| K913995 | VITALERT 3000 MONITORING SYSTEM | CCK | Substantially Equivalent | |
| K912533 | NARKOMED AV-E VENTILATOR | CBK | Substantially Equivalent | |
| K901713 | NARKOMED 4 ANESTHESIA SYSTEM | BSZ | Substantially Equivalent | |
| K900937 | O.R. DATA MANAGER | BSZ | Substantially Equivalent | |
| K900329 | NARKOMED 3 ANESTHESIA SYSTEM | BSZ | Substantially Equivalent | |
| K900328 | NARKOMED 2B ANESTHESIA SYSTEM | BSZ | Substantially Equivalent | |
| K882031 | VITALERT 2000 VITAL SIGNS MONITOR | DXO | Substantially Equivalent | |
| K873380 | VITALERT 1000 MONITORING SYSTEM | CCK | Substantially Equivalent | |
| K874415 | PRESSURE LIMIT CONTROL | CBK | Substantially Equivalent | |
| K874371 | ASCENDING VENTILATOR BELLOWS | CBK | Substantially Equivalent | |
| K873194 | SPECTRAMED RESPIRATORY GAS ANALYZER | CBS | Substantially Equivalent | |
| K873549 | PEDIATRIC BELLOWS | CBK | Substantially Equivalent | |
| K871886 | MODIFIED SPHYGMOMED NON-INVASIVE BLOOD PRES. MONIT | DXN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2517967 | 2517967 | DRAEGER, INC. | 3135 QUARRY RD., TELFORD, PA 18969 US | 2026 | No device listings on this registration |
| 3009348423 | 3009348423 | DRAEGER, INC. | 7256 S. Sam Houston W. Parkway, Houston, TX 77085 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- CBNApparatus, Gas-Scavenging
- BYEAttachment, Breathing, Positive End Expiratory Pressure
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- FLLContinuous Measurement Thermometer
- DJZDevices, Breath Trapping, Alcohol
- BSZGas-Machine, Anesthesia
- FMZIncubator, Neonatal
- BZRMixer, Breathing Gases, Anesthesia Inhalation
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)
- MLCMonitor, St Segment
- DPZOximeter, Ear
- BZGSpirometer, Diagnostic
- BZKSpirometer, Monitoring (W/Wo Alarm)
- GAPSuture, Nonabsorbable, Silk
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- BYRTransducer, Gas Pressure, Differential
- DXOTransducer, Pressure, Catheter Tip
- CADVaporizer, Anesthesia, Non-Heated
- CBKVentilator, Continuous, Facility Use
- FMTWarmer, Infant Radiant
Recall records
Showing 25 of 124| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2208-2026 | Atlan A350XL. Model Number: 8621600. anesthesia workstation | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. | Class I | Open, Classified | |
| Z-2207-2026 | Atlan A350. Model Number: 8211500. anesthesia workstation | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. | Class I | Open, Classified | |
| Z-0934-2026 | Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer. | A certain component of affected devices was not delivered within specification and contained impurities. | Class I | Open, Classified | |
| Z-0933-2026 | Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer. | A certain component of affected devices was not delivered within specification and contained impurities. | Class I | Open, Classified | |
| Z-0593-2026 | ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient. | Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. | Class I | Open, Classified | |
| Z-0592-2026 | ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient. | Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. | Class I | Open, Classified | |
| Z-0591-2026 | ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient. | Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. | Class I | Open, Classified | |
| Z-0590-2026 | ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient. | Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. | Class I | Open, Classified | |
| Z-2617-2025 | Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions Component: Not applicable | The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. | Class I | Open, Classified | |
| Z-2616-2025 | Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions Component: Not applicable | The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. | Class I | Open, Classified | |
| Z-2161-2025 | SafeStar 60A Plus Filter. Bidirectionally breathing system filter. | Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. | Class I | Open, Classified | |
| Z-2160-2025 | HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter. | Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. | Class I | Open, Classified | |
| Z-2159-2025 | SafeStar 55 Plus Filter. Bidirectionally breathing system filter. | Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. | Class I | Open, Classified | |
| Z-2158-2025 | SafeStar 90 Plus Filter. Bidirectionally breathing system filter. | Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. | Class I | Open, Classified | |
| Z-1499-2025 | Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex EPA Model/Catalog Number: MP17103 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only | The potential for cracks forming in the breathing circuit hose. | Class I | Open, Classified | |
| Z-1498-2025 | Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex (P)2 Model/Catalog Number: MP02752 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable | The potential for cracks forming in the breathing circuit hose. | Class I | Open, Classified | |
| Z-1497-2025 | Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 6 Model/Catalog Number: MP02744 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only | The potential for cracks forming in the breathing circuit hose. | Class I | Open, Classified | |
| Z-1496-2025 | Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catalog Number: MP02738 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable | The potential for cracks forming in the breathing circuit hose. | Class I | Open, Classified | |
| Z-1495-2025 | Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Number: MP02737 Software Version: Not applicable Product Description: Accessory for conducting medical gases between anesthesia machine and patient for anesthetic use. Kit is intended for single use only Component: Not applicable | The potential for cracks forming in the breathing circuit hose. | Class I | Open, Classified | |
| Z-1494-2025 | Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult Component: Not applicable | The potential for cracks forming in the breathing circuit hose. | Class I | Open, Classified | |
| Z-1493-2025 | Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an anesthesia machine or ventilator and adult patients. The breathing circuit is intended for single use only. Component: Not applicable | The potential for cracks forming in the breathing circuit hose. | Class I | Open, Classified | |
| Z-0668-2025 | Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. | Class I | Open, Classified | |
| Z-0667-2025 | Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. | Class I | Open, Classified | |
| Z-0305-2025 | Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. | Class I | Open, Classified | |
| Z-0304-2025 | Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. | Class I | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain