# Drägerwerk AG & Co. KGaA

- Location (FDA's records): Luebeck, DE
- FDA decisions: 7 (2019–2026): 7 510(k) clearances
- Names in FDA's records: Drägerwerk AG & Co. KGaA (3); Dragerwerk AG & CO Kgaa (2); Drägerwerk AG Co. Kgaa (2)
- Product codes: FMZ (2), BSZ (2), CAH (1), DSA (1), CBK (1)
- 510(k) review time since 2016: median 167 days, against 204 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 10 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 13 (12 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Draeger Medical, Inc.: 2 (https://510kreport.com/company/draeger-medical)
- Draegerwerk AG & CO Kgaa: 2 (https://510kreport.com/company/draegerwerk-ag-co-kgaa)
- Pharma System AB: 1 (https://510kreport.com/company/pharma-system)
- Flexicare Medical Limited.: 1 (https://510kreport.com/company/flexicare-medical)
- Vr Medical: 1 (https://510kreport.com/company/vr-medical)
- Integral Process Sas: 1 (https://510kreport.com/company/integral-process)

## Its most-cited devices
- K182859: Babyleo TN500 (2019), cited by 1
- K230931: Atlan (2023), cited by 1

## Recent decisions
- K252746: Atlan (A100); Atlan (A100 XL); Atlan (A350); Atlan (A350 XL) (May 21, 2026)
- K251619: Babyleo TN500 (Feb 13, 2026)
- K252827: IBP 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) (Dec 1, 2025)
- K230931: Atlan (Jul 23, 2023)
- K221836: Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus (Dec 7, 2022)
- K182859: Babyleo TN500 (Feb 22, 2019)
- K180779: Savina 300 (Jan 17, 2019)

Source page: https://510kreport.com/company/dragerwerk-ag-co-kgaa