# Draegerwerk AG & CO Kgaa

- Location (FDA's records): Luebeck, DE
- FDA decisions: 8 (2010–2026): 8 510(k) clearances
- Product codes: CBK (4), BZE (1), BTL (1), FMZ (1), CCK (1)
- 510(k) review time since 2016: median 302 days, against 309 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 9 (3 its own); citations of its devices by later devices: 9 (3 its own)
- Recalls linked to its devices: 6 (4 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)
- Fisher & Paykel Healthcare, Ltd.: 1 (https://510kreport.com/company/fisher-paykel-healthcare)
- Fisher & Paykel Electronics, Ltd.: 1 (https://510kreport.com/company/fisher-paykel-electronics)
- Ohmeda Medical: 1 (https://510kreport.com/company/ohmeda-medical)
- Drager Medical AG & Co. Kgaa: 1 (https://510kreport.com/company/drager-medical-ag-co-kgaa)

## Firms that cite its devices most
- Draeger Medical, Inc.: 2 (https://510kreport.com/company/draeger-medical)
- Drägerwerk AG & Co. KGaA: 2 (https://510kreport.com/company/dragerwerk-ag-co-kgaa)
- International Biomedical: 1 (https://510kreport.com/company/international-biomedical)
- Nihon Kohden Orangemed, Inc.: 1 (https://510kreport.com/company/nihon-kohden-orangemed)

## Its most-cited devices
- K093633: Infinity Acute Care System Workstation Critical Care (2010), cited by 5
- K162821: Babyleo TN500 (2017), cited by 2
- K222822: VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) (2023), cited by 1
- K222024: Evita V800, Evita V600 (2023), cited by 1

## Recent decisions
- K253647: Evita (V800); Evita (V600) (May 7, 2026)
- K242769: VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) (Apr 4, 2025)
- K222822: VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) (Jun 14, 2023)
- K222024: Evita V800, Evita V600 (May 16, 2023)
- K222207: Babylog VN800, Babylog VN600 (May 16, 2023)
- K221118: CO2 Mainstream Sensor (Apr 5, 2023)
- K162821: Babyleo TN500 (Jun 23, 2017)
- K093633: Infinity Acute Care System Workstation Critical Care (Mar 30, 2010)

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