Draegerwerk AG & Co. KGaA
LUEBECK Schleswig-Holstein, DE
DRAEGERWERK AG & CO. KGAA appears in FDA device records in LUEBECK Schleswig-Holstein, DE. FDA records list 8 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Draegerwerk AG & Co. KGaA between 2010 and 2026. The busiest year on record is 2023, with 4. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2017 | 1 |
| 2023 | 4 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253647 | Evita (V800); Evita (V600) | CBK | Substantially Equivalent | |
| K242769 | VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) | BTL | Substantially Equivalent | |
| K222822 | VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) | BZE | Substantially Equivalent | |
| K222207 | Babylog VN800, Babylog VN600 | CBK | Substantially Equivalent | |
| K222024 | Evita V800, Evita V600 | CBK | Substantially Equivalent | |
| K221118 | CO2 Mainstream Sensor | CCK | Substantially Equivalent | |
| K162821 | Babyleo TN500 | FMZ | Substantially Equivalent | |
| K093633 | INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE | CBK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3001104093 | 3023530182 | DRAEGERWERK AG & CO. KGAA | REVALSTRASSE 1, LUEBECK Schleswig-Holstein 23560 DE | 2026 | and 9 more, listed in full below |
| 9611500 | 3001104093 | Draegerwerk AG & Co. KGaA | 53/55 MOISLINGER ALLEE, LUEBECK Schleswig-Holstein 23542 DE | 2026 | and 37 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CBLAbsorbent, Carbon-Dioxide
- BSFAbsorber, Carbon-Dioxide
- 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.)
- NHPAnalyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
- OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
- BYEAttachment, Breathing, Positive End Expiratory Pressure
- BTCBag, Reservoir
- MQMBilirubin (Total And Unbound) In The Neonate Test System
- DXQBlood Pressure Cuff
- KDQBottle, Collection, Vacuum
- IKDCable, Electrode
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- CATCannula, Nasal, Oxygen
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- BYDCondenser, Heat And Moisture (Artificial Nose)
- BZAConnector, Airway (Extension)
- FLLContinuous Measurement Thermometer
- KZFDevice, Medical Examination, Ac Powered
- BYHDrain, Tee (Water Trap)
- CAHFilter, Bacterial, Breathing-Circuit
- BSZGas-Machine, Anesthesia
- BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- OGGHumidifier Nebulizer Kit
- FMZIncubator, Neonatal
- FTDLamp, Surgical
- FTALight, Surgical, Accessories
- BSJMask, Gas, Anesthetic
- OUGMedical Device Data System
- DQAOximeter
- FMPProtector, Skin Pressure
- CANRegulator, Pressure, Gas Cylinder
- BZOSet, Tubing And Support, Ventilator (W Harness)
- JAYSupport, Breathing Tube
- MSXSystem, Network And Communication, Physiological Monitors
- FQOTable, Operating-Room, Ac-Powered
- BXPTransducer, Gas Flow
- GAZTubing, Noninvasive
- CADVaporizer, Anesthesia, Non-Heated
- CBKVentilator, Continuous, Facility Use
- BTLVentilator, Emergency, Powered (Resuscitator)
- BZDVentilator, Non-Continuous (Respirator)
- FMTWarmer, Infant Radiant
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0971-2024 | Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL) | Internal backup battery may fail spontaneously while the Atlan is being operated without AC mains supply, resulting in unexpected shutdown of the device while running on batteries. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain