Datex Division Instrumentarium Corp.: FDA filings under this applicant name
FDA lists 55 510(k) clearances under the applicant name “Datex Division Instrumentarium Corp.” (first 1982, latest 1997), across 20 product codes in 3 review panels. Median 510(k) review time under this name: 100 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 |
|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 9 | 9 |
| DQA | Oximeter | 8 | 8 |
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | 7 | 7 |
| BSZ | Gas-Machine, Anesthesia | 4 | 4 |
| DPS | Electrocardiograph | 4 | 4 |
| CBS | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | 3 | 3 |
| DSK | Computer, Blood-Pressure | 3 | 3 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 3 | 3 |
| BZL | Computer, Oxygen-Uptake | 2 | 2 |
| DRI | Monitor, Line Isolation | 2 | 2 |
Plus 10 more product codes.
Review panels
- Anesthesiology (35)
- Cardiovascular (17)
- Neurology (2)
Most recent Datex Division Instrumentarium Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953175 | AS/3 ESTPR MODULE | MLD | 1997-02-06 | 580 |
| K961247 | AS/3 LIGHT MONITOR | DPS | 1996-10-23 | 205 |
| K943458 | AS/3 AIRWAY MODULE | CBS | 1995-02-14 | 211 |
| K945234 | AS/3 MEMORY MODULE, M0MEM | BSZ | 1995-01-27 | 92 |
| K933156 | DATEX AS/3 PATIENT MONITOR | DPS | 1994-12-30 | 549 |
| K933285 | DATEX AS/3 TM ANAESTHESIA MONITOR | BSZ | 1994-11-14 | 496 |
| K943456 | AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT | DQA | 1994-10-17 | 91 |
| K923172 | ANAESTHESIA RECORD KEEPER | BSZ | 1994-08-09 | 771 |
| K935477 | AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD | CCK | 1994-08-01 | 259 |
| K943457 | AS/3 PRESSURE TEMPERATURE MODULE, M-PT | DSK | 1994-07-27 | 9 |
45 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Datex Division Instrumentarium Corp..
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 Medical Instrumentation, Inc. (5 510(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 Division Instrumentarium Corp.?
FDA lists 55 510(k) clearances under the applicant name “Datex Division Instrumentarium Corp.” (first 1982, latest 1997), across 20 product codes in 3 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 Division Instrumentarium Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Datex Division Instrumentarium Corp. is 100 days.
Which FDA product codes appear under Datex Division Instrumentarium Corp.?
The most frequent FDA product codes under this applicant name are CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 9); DQA (Oximeter, 8); CBQ (Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration), 7).
Next steps
- See all 55 Datex Division Instrumentarium Corp. clearances with predicates and recalls
- Run predicate analysis for product code CCK, Datex Division Instrumentarium Corp.'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.