# Drager Medical AG & Co. Kgaa

- Location (FDA's records): Telford, PA
- FDA decisions: 3 (2005–2010): 3 510(k) clearances
- Product codes: CBK (3)
- Predicates its devices cite: 18 (3 its own); citations of its devices by later devices: 14 (3 its own)
- Recalls linked to its devices: 7 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Drager, Inc.: 10 (https://510kreport.com/company/drager)
- Drager Medizintechnik GmbH: 2 (https://510kreport.com/company/drager-medizintechnik)
- Hamilton Medical AG: 1 (https://510kreport.com/company/hamilton-medical)
- Siemens Elema AB: 1 (https://510kreport.com/company/siemens-elema)
- Puritan Bennett Corp.: 1 (https://510kreport.com/company/puritan-bennett)

## Firms that cite its devices most
- Hamilton Medical AG: 5 (https://510kreport.com/company/hamilton-medical)
- Puritan Bennett Corp.: 1 (https://510kreport.com/company/puritan-bennett)
- Respironics Novametrix, Inc.: 1 (https://510kreport.com/company/respironics-novametrix)
- Newport Medical Instruments, Inc.: 1 (https://510kreport.com/company/newport-medical-instruments)
- Draeger Medical, Inc.: 1 (https://510kreport.com/company/draeger-medical)
- Draegerwerk AG & CO Kgaa: 1 (https://510kreport.com/company/draegerwerk-ag-co-kgaa)
- Maquet Critical Care AB: 1 (https://510kreport.com/company/maquet-critical-care)

## Its most-cited devices
- K051263: Evitaxl with Option Smartcare (2005), cited by 9
- K072412: Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models 8415941, 8415942, 6871500 (2008), cited by 3
- K093632: Infinity Acute Care System Workstation Neonatal Care (2010), cited by 2

## Recent decisions
- K093632: Infinity Acute Care System Workstation Neonatal Care (Apr 5, 2010)
- K072412: Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models 8415941, 8415942, 6871500 (Feb 6, 2008)
- K051263: Evitaxl with Option Smartcare (Jul 12, 2005)

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