Datex-Ohmeda, Inc.: FDA filings under this applicant name
FDA lists 103 510(k) clearances under 4 spellings of the applicant name “Datex-Ohmeda, Inc.” (first 1998, latest 2026), across 21 product codes in 6 review panels. Median 510(k) review time under this name: 84 days. Since 2017 the median was 145 days, against 188 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under GE HealthCare, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 63 |
| 2013 | 3 | 125 |
| 2014 | 0 | — |
| 2015 | 3 | 266 |
| 2016 | 1 | 225 |
| 2017 | 2 | 132 |
| 2018 | 1 | 119 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 268 |
| 2022 | 2 | 114 |
| 2023 | 2 | 316 |
| 2024 | 0 | — |
| 2025 | 1 | 145 |
| 2026 | 2 | 208 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Datex-Ohmeda, Inc. took a median 145 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 188 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BSZ | Gas-Machine, Anesthesia | 24 | 24 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 15 | 15 |
| CBK | Ventilator, Continuous, Facility Use | 13 | 13 |
| MSX | System, Network And Communication, Physiological Monitors | 9 | 9 |
| DQA | Oximeter | 7 | 7 |
| CAD | Vaporizer, Anesthesia, Non-Heated | 6 | 6 |
| CAH | Filter, Bacterial, Breathing-Circuit | 5 | 5 |
| FMZ | Incubator, Neonatal | 4 | 4 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 3 | 3 |
| MLD | Monitor, St Segment With Alarm | 3 | 3 |
Plus 11 more product codes.
Review panels
- Anesthesiology (56)
- Cardiovascular (30)
- General Hospital (10)
- Neurology (3)
- Gastroenterology and Urology (2)
- Obstetrics and Gynecology (2)
Most recent Datex-Ohmeda, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254036 | Novii+ Wireless Patch System | HGM | 2026-08-10 | 237 |
| K260326 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | FMZ | 2026-07-28 | 179 |
| K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | FMZ | 2025-10-22 | 145 |
| K231964 | Novii+ Wireless Patch System | HGM | 2023-12-08 | 158 |
| K213867 | Carestation 750/750c | BSZ | 2023-03-28 | 473 |
| K213553 | Giraffe Incubator Carestation CS1 | FMZ | 2022-03-02 | 114 |
| K213551 | Giraffe Omnibed Carestation CS1 | FMT | 2022-03-02 | 114 |
| K210384 | CARESCAPE R860 | CBK | 2021-11-04 | 268 |
| K172702 | Tec 820, Tec 850 | CAD | 2018-01-04 | 119 |
| K172045 | Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2 | BSZ | 2017-11-03 | 120 |
93 earlier clearances. See the full list in Caduvo.
Recalls
56 product recalls in 26 recall events; 28 initiated in the last five years. Most recent: 2026-07-30.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
FDA spellings included
FDA records this applicant under 4 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Datex-Ohmeda, Inc. (59)
- Datex-Ohmeda (40)
- Datex Ohmeda, Inc. (3)
- Datex Ohmeda (1)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Datex Division Instrumentarium Corp. (55 510(k)s)
- Datex-Engstrom, Inc. (9 510(k)s)
- Datex Medical Instrumentation, Inc. (5 510(k)s)
- Datex-Ohmeda Inc., A Division of Instrumentarium C (2 510(k)s)
- Datex Engstrom AB (1 510(k)s)
- Datex-Ohmeda, Inc., A General Electric Company (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Datex-Ohmeda, Inc.?
FDA lists 103 510(k) clearances under 4 spellings of the applicant name “Datex-Ohmeda, Inc.” (first 1998, latest 2026), across 21 product codes in 6 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Datex-Ohmeda, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Datex-Ohmeda, Inc. is 84 days. Since 2017: 145 days, versus 188 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Datex-Ohmeda, Inc.?
The most frequent FDA product codes under this applicant name are BSZ (Gas-Machine, Anesthesia, 24); MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 15); CBK (Ventilator, Continuous, Facility Use, 13).
Next steps
- See all 103 Datex-Ohmeda, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BSZ, Datex-Ohmeda, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.