# Datex-Ohmeda, Inc.

- Location (FDA's records): Madison, WI
- FDA decisions: 103 (1998–2026): 103 510(k) clearances
- Names in FDA's records: Datex-Ohmeda, Inc. (59); Datex-Ohmeda (40); Datex Ohmeda, Inc. (3); Datex Ohmeda (1)
- Product codes: BSZ (24), MHX (15), CBK (13), MSX (9), DQA (7), CAD (6), CAH (5), FMZ (4), CCK (3), MLD (3), KNT (2), HGM (2)
- 510(k) review time since 2016: median 145 days, against 145 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 134 (82 its own); citations of its devices by later devices: 164 (82 its own)
- Recalls linked to its devices: 118 (37 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ohmeda Medical: 9 (https://510kreport.com/company/ohmeda-medical)
- Datex-Engstrom, Inc.: 5 (https://510kreport.com/company/datex-engstrom)
- Drager, Inc.: 5 (https://510kreport.com/company/drager)
- Datex-Ohmeda Inc., A Division of Instrumentarium C: 4 (https://510kreport.com/company/datex-ohmeda-a-division-of-instrumentarium-c)
- Datex Division Instrumentarium Corp.: 4 (https://510kreport.com/company/datex-division-instrumentarium)
- Aspect Medical Systems, Inc.: 4 (https://510kreport.com/company/aspect-medical-systems)
- Maquet Critical Care AB: 3 (https://510kreport.com/company/maquet-critical-care)
- Siemens Elema AB: 2 (https://510kreport.com/company/siemens-elema)

## Firms that cite its devices most
- GE Healthcare: 17 (https://510kreport.com/company/ge-healthcare)
- GE Healthcare Finland Oy: 9 (https://510kreport.com/company/ge-healthcare-finland)
- Draeger Medical, Inc.: 7 (https://510kreport.com/company/draeger-medical)
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 5 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)
- Hamilton Medical AG: 4 (https://510kreport.com/company/hamilton-medical)
- Maquet Critical Care AB: 4 (https://510kreport.com/company/maquet-critical-care)
- Elekon Industries U.S.A., Inc.: 3 (https://510kreport.com/company/elekon-industries-usa)
- Ge Medical Systems Information Technologies: 3 (https://510kreport.com/company/ge-medical-systems-information-technologies)

## Its most-cited devices
- K023366: Datex-Ohmeda 7900 Ventilator Enhancements (2003), cited by 7
- K983684: Datex-Ohmeda 3800+/3800P+ or 3900/3900P Pulse Oximeters (1998), cited by 6
- K090233: GE Datex-Ohmeda Aisys (2009), cited by 5
- K000706: Datex-Ohmeda Aestiva/5 with 7100 Ventilator (2000), cited by 4
- K021265: Datex-Ohmeda Hmef 500 (2002), cited by 4
- K001814: Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01) and Accessories (2000), cited by 4

## Recent decisions
- K254036: Novii+ Wireless Patch System (Aug 10, 2026)
- K260326: Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1) (Jul 28, 2026)
- K251663: Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) (Oct 22, 2025)
- K231964: Novii+ Wireless Patch System (Dec 8, 2023)
- K213867: Carestation 750/750c (Mar 28, 2023)
- K213553: Giraffe Incubator Carestation CS1 (Mar 2, 2022)
- K213551: Giraffe Omnibed Carestation CS1 (Mar 2, 2022)
- K210384: Carescape R860 (Nov 4, 2021)

Source page: https://510kreport.com/company/datex-ohmeda