# Drager Medizintechnik GmbH

- Location (FDA's records): Telford, PA
- FDA decisions: 8 (1999–2003): 8 510(k) clearances
- Product codes: CBK (5), FSY (1), FTD (1), FMZ (1)
- Predicates its devices cite: 2 (2 its own); citations of its devices by later devices: 17 (2 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Draeger Medical, Inc.: 3 (https://510kreport.com/company/draeger-medical)
- Drager Medical AG & Co. Kgaa: 2 (https://510kreport.com/company/drager-medical-ag-co-kgaa)
- Hamilton Medical AG: 2 (https://510kreport.com/company/hamilton-medical)
- Drager Medical B.V.: 2 (https://510kreport.com/company/drager-medical)
- Maquet Critical Care AB: 1 (https://510kreport.com/company/maquet-critical-care)
- Trumpf Medical Systems, Inc.: 1 (https://510kreport.com/company/trumpf-medical-systems)
- Atom Medical Corporation: 1 (https://510kreport.com/company/atom-medical)
- Smiths Medical International, Ltd.: 1 (https://510kreport.com/company/smiths-medical-international)

## Its most-cited devices
- K010093: Non-Invasive Ventilation Niv Option, Model 84 14 474 (2001), cited by 6
- K003068: Savina (2001), cited by 5
- K023289: Option Niv, Model 8414115, Upgrade Kit Niv, Model 8414072 (2003), cited by 2
- K984611: Drager Sola Series, Models 1000/700/500/300 (1999), cited by 1
- K010793: Oxylog 1000, Model 2M86840 (2001), cited by 1
- K010724: Sola 700,Sola 500, Sola 300 (2001), cited by 1

## Recent decisions
- K023289: Option Niv, Model 8414115, Upgrade Kit Niv, Model 8414072 (Jan 15, 2003)
- K010793: Oxylog 1000, Model 2M86840 (Dec 20, 2001)
- K012177: Ventview, Model 8414095 (Sep 4, 2001)
- K003068: Savina (Jun 25, 2001)
- K010093: Non-Invasive Ventilation Niv Option, Model 84 14 474 (Jun 14, 2001)
- K010724: Sola 700,Sola 500, Sola 300 (Jun 7, 2001)
- K003067: CALEO (Dec 13, 2000)
- K984611: Drager Sola Series, Models 1000/700/500/300 (Mar 29, 1999)

Source page: https://510kreport.com/company/drager-medizintechnik