# Draeger Medical Systems, Inc.

- Location (FDA's records): Danvers, MA
- FDA decisions: 49 (2003–2026): 49 510(k) clearances
- Product codes: MHX (25), MSX (5), DQA (3), FMT (3), DRQ (2), LBI (2), KOI (1), FPL (1), NHP (1), CBK (1), DXN (1), DSI (1)
- 510(k) review time since 2016: median 201 days, against 196 for FDA's reviews in the same codes and years (3 of 8 faster)
- Predicates its devices cite: 103 (46 its own); citations of its devices by later devices: 61 (46 its own)
- Recalls linked to its devices: 31 (5 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Siemens Medical Solutions USA, Inc.: 36 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Masimo Corporation: 4 (https://510kreport.com/company/masimo)
- Hill-Rom Air-Shields: 2 (https://510kreport.com/company/hill-rom-air-shields)
- Draeger Medical, Inc.: 2 (https://510kreport.com/company/draeger-medical)
- Organon Teknika Corp.: 1 (https://510kreport.com/company/organon-teknika)
- International Biomedical: 1 (https://510kreport.com/company/international-biomedical)
- Drager, Inc.: 1 (https://510kreport.com/company/drager)
- Drager Medical B.V.: 1 (https://510kreport.com/company/drager-medical)

## Firms that cite its devices most
- Draeger Medical, Inc.: 3 (https://510kreport.com/company/draeger-medical)
- Snap40, Ltd.: 2 (https://510kreport.com/company/snap40)
- Mespere Lifesciences, Inc.: 1 (https://510kreport.com/company/mespere-lifesciences)
- Nihon Kohden Corporation: 1 (https://510kreport.com/company/nihon-kohden)
- Mammendorfer Institut Fur Physik Und Medizin GmbH: 1 (https://510kreport.com/company/mammendorfer-institut-fur-physik-und-medizin)
- Draeger Medical AG & Co. Kgaa: 1 (https://510kreport.com/company/draeger-medical-ag-co-kgaa)
- Draeger Medical Sytems, Inc.: 1 (https://510kreport.com/company/draeger-medical-sytems)
- Current Health, Ltd.: 1 (https://510kreport.com/company/current-health)

## Its most-cited devices
- K033600: Infinity Gammaxl (2003), cited by 5
- K040188: Infinity Gammaxl and SC 6802XL with the Scio Gas Module (2004), cited by 4
- K113798: Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set (2012), cited by 4
- K151860: Infinity CentralStation Wide (2015), cited by 3
- K060254: Modification to Infinity Explorer (2006), cited by 3
- K043439: Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta XL/Vista XL/Gamma X XL and SC 7000/8000/9000XL (2005), cited by 3

## Recent decisions
- K260579: Infinity® Acute Care System (IACS) – VG8.1 (Aug 20, 2026)
- K243606: Babyroo TN300 (Jan 17, 2025)
- K240312: Infinity CentralStation Wide (Aug 1, 2024)
- K233834: Infinity Gateway Suite (Jul 12, 2024)
- K231477: Infinity CentralStation Wide, Infinity M300, Infinity M300+ (Oct 17, 2023)
- K230278: Babyroo TN300 (May 30, 2023)
- K203579: Infinity Gateway Suite (Jun 7, 2022)
- K203088: Infinity Acute Care System (IACS) Monitoring System (Feb 1, 2022)

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