Datex Medical Instrumentation, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Datex Medical Instrumentation, Inc.” (first 1991, latest 1997), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 91 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CBS | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | 1 | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| KOI | Stimulator, Nerve, Peripheral, Electric | 1 | 1 |
Review panels
- Anesthesiology (3)
- Cardiovascular (2)
Most recent Datex Medical Instrumentation, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K955026 | AS/3 NMT MODULE | KOI | 1997-04-28 | 543 |
| K961063 | AS/3 CARDIAC OUTPUT & SVO2 MODULE | DQK | 1996-05-31 | 74 |
| K960490 | AS/3 COMPACT AIRWAY MODULE M-CAIOV | CBS | 1996-05-03 | 91 |
| K953006 | AS/3 NETWORK LINK | CCK | 1995-09-27 | 91 |
| K912530 | CARDIOCAP II(TM) | DXN | 1991-09-05 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Datex Medical Instrumentation, Inc..
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.
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 Ohmeda, Inc. (4 510(k)s)
- Datex Engstrom AB (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Datex Medical Instrumentation, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Datex Medical Instrumentation, Inc.” (first 1991, latest 1997), across 5 product codes in 2 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 Medical Instrumentation, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Datex Medical Instrumentation, Inc. is 91 days.
Which FDA product codes appear under Datex Medical Instrumentation, Inc.?
The most frequent FDA product codes under this applicant name are CBS (Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.), 1); CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 1); DQK (Computer, Diagnostic, Programmable, 1).
Next steps
- See all 5 Datex Medical Instrumentation, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CBS, Datex Medical Instrumentation, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.