Jaeger Medical GmbH
HOECHBERG Bavaria, DE
Jaeger Medical GmbH appears in FDA device records in HOECHBERG Bavaria, DE. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 79 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to Jaeger Medical GmbH 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.
- Carefusion 211 Increcall
- Carefusion 211 Inc dba Carefusionenforcement report, recall
- Vyaire Medical, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 11 510(k) clearances for Jaeger Medical GmbH between 2017 and 2024. The busiest year on record is 2019, with 3. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 3 |
| 2020 | 1 |
| 2021 | 2 |
| 2023 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K230915 | AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask | CCK | Substantially Equivalent | |
| K231380 | AirLife DuoTherm™ Humidification System | BTT | Substantially Equivalent | |
| K201082 | LTV2 Series Ventilators | CBK | Substantially Equivalent | |
| K211294 | Multi-Link X2 ECG Cable and Leadwire System | DSA | Substantially Equivalent | |
| K200510 | Multi-LinkTM X2 ECG Adapter and Leadwires | DSA | Substantially Equivalent | |
| K191273 | Multi-Link X2 ECG and SpO2 Adapter | DSA | Substantially Equivalent | |
| K183567 | Vyntus/SentrySuite Product Line | BZC | Substantially Equivalent | |
| K190853 | Vyntus BODY | BZC | Substantially Equivalent | |
| K181524 | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART | BZC | Substantially Equivalent | |
| K171678 | Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable | CCK | Substantially Equivalent | |
| K170378 | AirLife Adult Heated Wire BiPAP/NIV Circuit | BZE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9615102 | 1000271197 | Jaeger Medical GmbH | LEIBNIZSTRASSE 7, HOECHBERG Bavaria 97204 DE | 2026 | and 20 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CCJAnalyzer, Gas, Carbon-Monoxide, Gaseous-Phase
- BSEAnalyzer, Gas, Helium, Gaseous-Phase
- CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- BTYCalculator, Predicted Values, Pulmonary Function
- BZCCalculator, Pulmonary Function Data
- BXWCalibrator, Volume, Gas
- BXJClip, Nose
- DQKComputer, Diagnostic, Programmable
- BZLComputer, Oxygen-Uptake
- DPSElectrocardiograph
- IKNElectromyograph, Diagnostic
- ISDExerciser, Measuring
- CAHFilter, Bacterial, Breathing-Circuit
- BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- OUGMedical Device Data System
- BZHMeter, Peak Flow, Spirometry
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- MLCMonitor, St Segment
- BYPMouthpiece, Breathing
- DQAOximeter
- CCMPlethysmograph, Pressure
- JEHPlethysmograph, Volume
- CANRegulator, Pressure, Gas Cylinder
- BZGSpirometer, Diagnostic
- OLVStandard Polysomnograph With Electroencephalograph
- BXPTransducer, Gas Flow
- ISPValve, Prosthesis
- CBKVentilator, Continuous, Facility Use
- MNRVentilatory Effort Recorder
Recall records
Showing 25 of 79| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1698-2025 | Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH265 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit Kit Dual-limb, Dual-heat, high-flow circuit (>4 L/min) Contains AH165 Circuit, AH290 Chamber Component: No. a conduit for respiratory gas between the patient and a ventilator. | Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure. | Class I | Open, Classified | |
| Z-1697-2025 | Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit dual-limb, dual-heat, high-flow circuit (>4 L/min) Component: No. a conduit for respiratory gas between the patient and a ventilator. | Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure. | Class I | Open, Classified | |
| Z-1730-2024 | Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX. The TwinTube sample line 240cm is connected to the adapter for DVT. Twin Tube Probenschlauch (707004), which is sold outside the US only. Used in breath analysis for metabolic response study. | Potential of the nozzle separating during patient use. | Class I | Open, Classified | |
| Z-1065-2024 | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004 | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017. | Class I | Open, Classified | |
| Z-1064-2024 | AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017 | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017. | Class I | Open, Classified | |
| Z-1063-2024 | AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2 | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017. | Class I | Open, Classified | |
| Z-1062-2024 | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005F | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017. | Class I | Open, Classified | |
| Z-1061-2024 | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005 | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017. | Class I | Open, Classified | |
| Z-1060-2024 | AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2 | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017. | Class I | Open, Classified | |
| Z-1059-2024 | AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017. | Class I | Open, Classified | |
| Z-1058-2024 | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001 | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017. | Class I | Open, Classified | |
| Z-1057-2024 | AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000, | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017. | Class I | Open, Classified | |
| Z-0489-2024 | vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV) | Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were distributed in the U.S. | Class II | Completed | |
| Z-0488-2024 | vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV) | Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were distributed in the U.S. | Class II | Completed | |
| Z-1967-2023 | bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator | Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive and the device application stops responding (APP Hang). When this occurs, if the user continues to interact with the touchscreen, a message will appear that states DeviceSoftware.Application is not responding or a decommission screen will appear on the user interface. The ventilator will issue both an audible and visual alarm. Ventilation continues without interruption with the settings applied prior to the APP Hang error. 2. The potential for a use error has been identified if the operator applies the proposed settings without confirming the settings are suitable for the patient. | Class II | Completed | |
| Z-1966-2023 | bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator | Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive and the device application stops responding (APP Hang). When this occurs, if the user continues to interact with the touchscreen, a message will appear that states DeviceSoftware.Application is not responding or a decommission screen will appear on the user interface. The ventilator will issue both an audible and visual alarm. Ventilation continues without interruption with the settings applied prior to the APP Hang error. 2. The potential for a use error has been identified if the operator applies the proposed settings without confirming the settings are suitable for the patient. | Class II | Completed | |
| Z-0622-2022 | bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista 1000/1000e ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients, and optionally, infant and neonatal patients. | Potential cessation in ventilation can occur under specific conditions. | Class I | Terminated | |
| Z-1439-2020 | bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilation system with an integrated air compressing system. bellavista uses room air and high-pressure oxygen. Air enters through a fresh gas intake port and is compressed together with the oxygen by the blower. Oxygen enters through a high pressure inlet. An electronic mixer valve provides for the operator-set concentration. Gas is supplied to the patient via the microprocessor controlled inspiratory valve. | The G6 bellavista 1000 US ventilators may experience intermittent failures: Lack of acoustic high priority alarm, presence of a 'no alarm' condition, or presence of non-responsive touch screen. | Class II | Terminated | |
| Z-1386-2019 | enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions. | Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming. | Class I | Terminated | |
| Z-1385-2019 | enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions. | Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming. | Class I | Terminated | |
| Z-2826-2018 | The Tri-Flo Subglottic Suction System | Vyaire Medical has discovered potential patient safety risk with associated with the Tri-Flow Subglottic Suction System. The distal soft tip of the catheter has been identified as having the potential to break off during patient use and result in aspiration of a solid foreign body. | Class I | Terminated | |
| Z-2553-2018 | AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with mask, 28" large bore tubing, pressure-relief valve, Part Number 2K8018; b. Pediatric, with mask, 40" oxygen reservoir bag, pressure-relief valve, Part Number 2K8008; c. Pediatric, Resuscitation kit with neonatal, infant and pediatric masks, Part Number RE1DK5445D; d. Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve, Part Number 2K8039 Manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own. The devices are intended for use as single patient use resuscitator devices for pulmonary resuscitation. | An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use. | Class I | Terminated | |
| Z-2552-2018 | AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask, oxygen reservoir bag, Part Number 2K8004; b. Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve, Part Number 2K8035C2; c. Adult, with mask, 28" large bore tubing, Part Number 2K8017; d. Adult, with mask, 40" oxygen reservoir tubing, Part Number 2K8005; e. Adult, with mask, 40" oxygen reservoir tubing, PEEP valve, Part Number 2K8036; f. Adult, without mask, 40" oxygen reservoir tubing, Part Number 2K8001; g. Adult, with mask, oxygen reservoir bag, manometer, PEEP valve, Part Number 2K8035M; h. Adult, with mask, oxygen reservoir bag, CO2 detector, Part Number 2K8004C2; Manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own. The devices are intended for use as single patient use resuscitator devices for pulmonary resuscitation. | An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use. | Class I | Terminated | |
| Z-3080-2017 | AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE 25G 5/8", LUER SLIP PROTECTIVE SHEATH, 3.2 IU, STERILE R, Rx ONLY, CAREFUSION Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect sub-assembly which includes a larger needle (23 Gage, 1" needle), larger syringe (3mL), and larger amount of heparin (113IU), than what is intended for the kit. | Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect sub-assembly which includes a larger needle (23 Gage, 1" needle), larger syringe (3mL), and larger amount of heparin (113IU), than what is intended for the kit. | Class II | Terminated | |
| Z-1581-2018 | AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own. | The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator. | Class I | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain