# Draeger Medical, Inc.

- Location (FDA's records): Telford, PA
- FDA decisions: 94 (1977–2014): 94 510(k) clearances
- Names in FDA's records: Draeger Medical, Inc. (78); Draeger Medical AG & Co. KG (10); Draeger Medical GmbH (4); Draeger Medical B.V. (2)
- Product codes: BSZ (37), CBK (14), CAD (7), CCK (6), BYE (4), DXN (3), CAP (3), CBN (2), FLL (2), BYR (1), CBS (1), FMT (1)
- Predicates its devices cite: 106 (35 its own); citations of its devices by later devices: 63 (35 its own)
- Recalls linked to its devices: 34 (16 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Drager, Inc.: 7 (https://510kreport.com/company/drager)
- Datex-Ohmeda, Inc.: 7 (https://510kreport.com/company/datex-ohmeda)
- Siemens Medical Solutions USA, Inc.: 4 (https://510kreport.com/company/siemens-medical-solutions-usa)
- GE Healthcare Finland Oy: 4 (https://510kreport.com/company/ge-healthcare-finland)
- Fisher & Paykel Healthcare, Ltd.: 4 (https://510kreport.com/company/fisher-paykel-healthcare)
- Drager Medizintechnik GmbH: 3 (https://510kreport.com/company/drager-medizintechnik)
- Draeger Medical Systems, Inc.: 3 (https://510kreport.com/company/draeger-medical-systems)
- Ohmeda Medical: 3 (https://510kreport.com/company/ohmeda-medical)

## Firms that cite its devices most
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 6 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)
- Draegerwerk AG & CO Kgaa: 2 (https://510kreport.com/company/draegerwerk-ag-co-kgaa)
- Draeger Medical Systems, Inc.: 2 (https://510kreport.com/company/draeger-medical-systems)
- Draeget Medical AG & Co. Kgaa: 2 (https://510kreport.com/company/draeget-medical-ag-co-kgaa)
- Draeger Medical AG & Co. Kgaa: 2 (https://510kreport.com/company/draeger-medical-ag-co-kgaa)
- Drägerwerk AG & Co. KGaA: 2 (https://510kreport.com/company/dragerwerk-ag-co-kgaa)
- Charles A. Smith: 1 (https://510kreport.com/company/charles-a-smith)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)

## Its most-cited devices
- K012139: Vamos Anesthetic Gas Monitor (2002), cited by 5
- K040847: Modification to Vamos Anesthetic Gas Monitor (2004), cited by 4
- K042607: Primus US (2004), cited by 4
- K983635: Julian Anesthesia Workstation, Model # Julian (1999), cited by 2
- K011404: Fabius GS Anesthesia System, Model Fabius GS (2002), cited by 2
- K930351: Narkomed 2C Anesthesia System (1993), cited by 2

## Recent decisions
- K121886: Savina 300 Savina 300, Country Variants (Aug 8, 2014)
- K133886: Perseus A500 (Jun 20, 2014)
- K121999: General Purpose Temperature Probe, Skin Temperature Probe (Feb 28, 2013)
- K103035: Smartpilot View Model MK04500 (Mar 28, 2012)
- K102618: Ventstar Heated, Infinity ID Breathing Circuit Heated (Dec 10, 2010)
- K092029: Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu, Model MP00310 (Aug 6, 2010)
- K100941: Infinity Mcable - Mainstream CO2 (Apr 23, 2010)
- K092999: NBP Cuff (Nov 24, 2009)

Source page: https://510kreport.com/company/draeger-medical