FDA product code DTX: Gas Control Unit, Cardiopulmonary Bypass
DTX is the FDA product code for gas control unit, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4300 and reviewed by the Cardiovascular panel. FDA has cleared 10 510(k) submissions under DTX, from 8 different applicants. The average 510(k) review took 74 days (median 62).
Classification
| Field | Value |
|---|---|
| Device name | Gas Control Unit, Cardiopulmonary Bypass |
| Device class | Class II |
| Regulation | 21 CFR 870.4300 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for DTX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 90 |
| 2020 | 1 | 28 |
| 2021 | 1 | 60 |
Compare with all 510(k) review times · Search every DTX clearance
Top DTX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Spectrum Medical , Ltd. | 3 | 2021-05-04 |
| Sorin Group Deutschland GmbH | 1 | 2010-12-09 |
| Sechrist Industries, Inc. | 1 | 2003-01-17 |
| Coeur Laboratories, Inc. | 1 | 1997-03-28 |
| 3M Health Care, Sarns | 1 | 1986-12-11 |
3 more applicants have DTX clearances. See the full list in Caduvo.
Most recent DTX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K210669 | Spectrum Medical , Ltd. | Quantum Mini Ventilation Module | 2021-05-04 | 60 |
| K202733 | Spectrum Medical , Ltd. | Quantum Ventilation Module | 2020-10-16 | 28 |
| K181942 | Spectrum Medical , Ltd. | Quantum Ventilation Module | 2018-10-18 | 90 |
| K101046 | Sorin Group Deutschland GmbH | STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM | 2010-12-09 | 239 |
| K023745 | Sechrist Industries, Inc. | SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G | 2003-01-17 | 71 |
Recalls for DTX devices
openFDA lists no recalls for product code DTX.
Frequently asked questions
What is FDA product code DTX?
DTX is the FDA product code for gas control unit, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4300 and reviewed by the Cardiovascular panel.
What device class is DTX?
Class II, regulation 21 CFR 870.4300. Typical premarket route: 510(k).
How long does a 510(k) take for product code DTX?
Across 10 cleared submissions the average was 74 days from receipt to decision (median 62).
Which companies have the most DTX clearances?
Spectrum Medical , Ltd. (3); Sorin Group Deutschland GmbH (1); Sechrist Industries, Inc. (1); Coeur Laboratories, Inc. (1); 3M Health Care, Sarns (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DTX
- Run a recall and safety report across every DTX manufacturer
- Watch product code DTX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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