Datex-Engstrom, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Datex-Engstrom, Inc.” (first 1998, latest 1998), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 152 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 |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | 2 | 2 |
| BSZ | Gas-Machine, Anesthesia | 1 | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
| DPS | Electrocardiograph | 1 | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 1 | 1 |
| MSX | System, Network And Communication, Physiological Monitors | 1 | 1 |
Review panels
Most recent Datex-Engstrom, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983366 | TRIP TONOMETRY CATHETER, 16F | KNT | 1998-12-23 | 90 |
| K982091 | CS/3 COMPACT AIRWAY MODULE, M-COVX | MHX | 1998-12-22 | 190 |
| K981378 | DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1 | DRT | 1998-11-03 | 201 |
| K973985 | AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU) | BSZ | 1998-10-30 | 375 |
| K980362 | MRI COMPATIBLE MONITOR AND ACCESSORIES | DPS | 1998-06-30 | 152 |
| K974792 | CS/3(TM) MONITORS* | DSI | 1998-06-02 | 162 |
| K980384 | TRIP TONOMETRY CATHETER, 18F | CCK | 1998-05-01 | 88 |
| K974747 | CS/3 ARRHYTHMIA WORKSTATION | DSI | 1998-04-23 | 125 |
| K974101 | DATEX-ENGSTROM NETWORK | MSX | 1998-02-06 | 99 |
Recalls
openFDA lists no recalls under a recalling firm named Datex-Engstrom, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Datex-Engstrom, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Datex-Engstrom, Inc.” (first 1998, latest 1998), across 8 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-Engstrom, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Datex-Engstrom, Inc. is 152 days.
Which FDA product codes appear under Datex-Engstrom, Inc.?
The most frequent FDA product codes under this applicant name are DSI (Detector And Alarm, Arrhythmia, 2); BSZ (Gas-Machine, Anesthesia, 1); CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 1).
Next steps
- See all 9 Datex-Engstrom, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSI, Datex-Engstrom, 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.