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Data / Medical devices / Germany / Draegerwerk AG & Co. KGaA

Draegerwerk AG & Co. KGaA: FDA-registered device maker in LUEBECK Schleswig-Holstein, Germany, 38 510(k) clearances

Draegerwerk AG & Co. KGaA is registered with the FDA (registration 9611500) in LUEBECK Schleswig-Holstein, Germany. It lists 47 device types. The FDA files 38 510(k) clearances under its listings, the newest dated May 21, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Draegerwerk AG & Co. KGaA
FDA registration number
9611500
FEI number
3001104093
Address
53/55 Moislinger Allee, LUEBECK Schleswig-Holstein, Germany, 23542
Owner or operator
Draegerwerk AG & Co. KGaA (8010046)
Roles
Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
First device listed
December 15, 1977
Registered through
2027
Brand names listed
90 -LUERLOCK FOR NEONATES, ADAPTER FOR THERMOMETER, Adapter , Box10, Adapter 9/16" to 6mm, Adapter NBP, Ambia, Anesthesia Circuit Kit Basic (P) 1, Anesthesia Circuit Kit Basic 2 and more

Devices it lists

DeviceProduct codeClassRoleSource
Absorbent, Carbon-DioxideCBL1Specification developeraccessdata.fda.gov
Absorber, Carbon-DioxideBSF1Specification developeraccessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)NHO2Manufacturer, Specification developeraccessdata.fda.gov
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)CBQ2Manufacturer, Specification developeraccessdata.fda.gov
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)CBS2Specification developeraccessdata.fda.gov
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)NHQ2Manufacturer, Specification developeraccessdata.fda.gov
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)CBR2Specification developeraccessdata.fda.gov
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)NHP2Specification developeraccessdata.fda.gov
Anesthesia Breathing Circuit Kit (Adult & Pediatric)OFP1Specification developeraccessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum PoweredGCX2Manufactureraccessdata.fda.gov
Attachment, Breathing, Positive End Expiratory PressureBYE2Specification developeraccessdata.fda.gov
Bag, ReservoirBTC1Specification developeraccessdata.fda.gov
Bilirubin (Total And Unbound) In The Neonate Test SystemMQM1Exporter to the US, Specification developeraccessdata.fda.gov
Blood Pressure CuffDXQ2Specification developeraccessdata.fda.gov
Bottle, Collection, VacuumKDQ2Specification developeraccessdata.fda.gov
Cable, ElectrodeIKD2Specification developeraccessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)DSA2Specification developeraccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Specification developeraccessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI1Specification developeraccessdata.fda.gov
Condenser, Heat And Moisture (Artificial Nose)BYD1Manufactureraccessdata.fda.gov
Connector, Airway (Extension)BZA1Manufactureraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Specification developeraccessdata.fda.gov
Device, Medical Examination, Ac PoweredKZF1Specification developeraccessdata.fda.gov
Drain, Tee (Water Trap)BYH1Manufactureraccessdata.fda.gov
Filter, Bacterial, Breathing-CircuitCAH2Manufacturer, Specification developeraccessdata.fda.gov
Gas-Machine, AnesthesiaBSZ2Manufacturer, Specification developeraccessdata.fda.gov
Heater, Breathing System W/Wo Controller (Not Humidifier Or NebulizerBZE2Specification developeraccessdata.fda.gov
Humidifier Nebulizer KitOGG2Specification developeraccessdata.fda.gov
Incubator, NeonatalFMZ2Manufacturer, Specification developeraccessdata.fda.gov
Lamp, SurgicalFTD2Manufactureraccessdata.fda.gov
Light, Surgical, AccessoriesFTA2Specification developeraccessdata.fda.gov
Mask, Gas, AnestheticBSJ1Specification developeraccessdata.fda.gov
OximeterDQA2Manufacturer, Specification developeraccessdata.fda.gov
Protector, Skin PressureFMP1Specification developeraccessdata.fda.gov
Regulator, Pressure, Gas CylinderCAN1Specification developeraccessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)BZO1Manufactureraccessdata.fda.gov
Support, Breathing TubeJAY1Specification developeraccessdata.fda.gov
System, Network And Communication, Physiological MonitorsMSX2Repackager or relabeleraccessdata.fda.gov
Table, Operating-Room, Ac-PoweredFQO1Manufactureraccessdata.fda.gov
Transducer, Gas FlowBXP1Manufactureraccessdata.fda.gov
Tubing, NoninvasiveGAZ2Manufactureraccessdata.fda.gov
Vaporizer, Anesthesia, Non-HeatedCAD2Manufactureraccessdata.fda.gov
Ventilator, Continuous, Facility UseCBK2Manufacturer, Specification developeraccessdata.fda.gov
Ventilator, Emergency, Powered (Resuscitator)BTL2Specification developeraccessdata.fda.gov
Ventilator, Non-Continuous (Respirator)BZD2Specification developeraccessdata.fda.gov
Warmer, Infant RadiantFMT2Manufacturer, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 21, 2026K252746Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)BSZSubstantially EquivalentDrägerwerk AG Co. Kgaaaccessdata.fda.gov
May 7, 2026K253647Evita (V800); Evita (V600)CBKSubstantially EquivalentDraegerwerk AG & CO Kgaaaccessdata.fda.gov
February 13, 2026K251619Babyleo TN500FMZSubstantially EquivalentDrägerwerk AG & Co. KGaAaccessdata.fda.gov
December 1, 2025K252827IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559)DSASubstantially EquivalentDrägerwerk AG & Co. KGaAaccessdata.fda.gov
April 4, 2025K242769VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)BTLSubstantially EquivalentDraegerwerk AG & CO Kgaaaccessdata.fda.gov
January 17, 2025K243606Babyroo TN300FMTSubstantially EquivalentDraeger Medical Systems, Inc.accessdata.fda.gov
July 23, 2023K230931AtlanBSZSubstantially EquivalentDrägerwerk AG Co. Kgaaaccessdata.fda.gov
June 14, 2023K222822VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)BZESubstantially EquivalentDraegerwerk AG & CO Kgaaaccessdata.fda.gov
May 16, 2023K222207Babylog VN800, Babylog VN600CBKSubstantially EquivalentDraegerwerk AG & CO Kgaaaccessdata.fda.gov
April 5, 2023K221118CO2 Mainstream SensorCCKSubstantially EquivalentDraegerwerk AG & CO Kgaaaccessdata.fda.gov
December 7, 2022K221836Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusCAHSubstantially EquivalentDrägerwerk AG & Co. KGaAaccessdata.fda.gov
February 22, 2019K182859Babyleo TN500FMZSubstantially EquivalentDragerwerk AG & CO Kgaaaccessdata.fda.gov
January 17, 2019K180779Savina 300CBKSubstantially EquivalentDragerwerk AG & CO Kgaaaccessdata.fda.gov
November 13, 2014K133175DRAEGER JAUNDICE METER JM-105MQMSubstantially EquivalentDraeger Medical Systems, Inc.accessdata.fda.gov
June 20, 2014K133886PERSEUS A500BSZSubstantially EquivalentDraeger Medical GmbHaccessdata.fda.gov
October 11, 2013K131502SEATTLE - PAPBZDSubstantially EquivalentSeattle Childrens Hospitalaccessdata.fda.gov
March 8, 2013K123776POLARIS 100/200FTDSubstantially EquivalentDrager Medical GmbHaccessdata.fda.gov
February 28, 2013K121999GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBEFLLSubstantially EquivalentDraeger Medical GmbHaccessdata.fda.gov
March 28, 2012K103035SMARTPILOT VIEW MODEL MK04500BSZSubstantially EquivalentDraeger Medical GmbHaccessdata.fda.gov
August 6, 2010K092029VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310BYESubstantially EquivalentDraeger Medical AG & Co. KGaccessdata.fda.gov
April 23, 2010K100941INFINITY MCABLE - MAINSTREAM CO2CCKSubstantially EquivalentDraeger Medical AG & Co. KGaccessdata.fda.gov
March 30, 2010K093633INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARECBKSubstantially EquivalentDraegerwerk AG & CO Kgaaaccessdata.fda.gov
November 24, 2009K092999NBP CUFFDXQSubstantially EquivalentDraeger Medical AG & Co. KGaccessdata.fda.gov
July 30, 2008K072884FABIUS MRIBSZSubstantially EquivalentDraeger Medical AG & Co. KGaccessdata.fda.gov
April 7, 2008K072885CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110CBKSubstantially EquivalentDraeger Medical AG & Co. KGaccessdata.fda.gov
January 31, 2008K072002FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55CAHSubstantially EquivalentDraeger Medical AG & Co. KGaccessdata.fda.gov
October 31, 2006K062267OXYLOG 3000CBKSubstantially EquivalentDrager Medical B.V.accessdata.fda.gov
April 4, 2006K060254MODIFICATION TO INFINITY EXPLORERMSXSubstantially EquivalentDraeger Medical Systems, Inc.accessdata.fda.gov
November 26, 2004K042607PRIMUS USBSZSubstantially EquivalentDraeger Medical, Inc.accessdata.fda.gov
September 23, 2004K042276D-VAPORCADSubstantially EquivalentDraeger Medical, Inc.accessdata.fda.gov
June 17, 2004K040847MODIFICATION TO VAMOS ANESTHETIC GAS MONITORCCKSubstantially EquivalentDraeger Medical, Inc.accessdata.fda.gov
January 17, 2002K012139VAMOS ANESTHETIC GAS MONITORCCKSubstantially EquivalentDraeger Medical, Inc.accessdata.fda.gov
December 20, 2001K010793OXYLOG 1000, MODEL 2M86840CBKSubstantially EquivalentDrager Medizintechnik GmbHaccessdata.fda.gov
June 25, 2001K003068SAVINACBKSubstantially EquivalentDrager Medizintechnik GmbHaccessdata.fda.gov
December 13, 2000K003067CALEOFMZSubstantially EquivalentDrager Medizintechnik GmbHaccessdata.fda.gov
June 17, 1998K974176BABYLOG 8000 PLUSCBKSubstantially EquivalentDrager, Inc.accessdata.fda.gov
October 3, 1997K971198BABYTHERM 8004 BABYTHERM 8010FMTSubstantially EquivalentDrager, Inc.accessdata.fda.gov
September 16, 1997K971923DRAGER-VAPOR 2000CADSubstantially EquivalentDraeger Medical, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
November 17, 202393544Class IIOngoingAtlan, 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.accessdata.fda.gov

Compare with other makers

Updated May 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.