DTX
10 FDA 510(k) clearances · Product code
65 daysmedian time to decision
239 days90th percentile
10clearances measured
FDA profile
- Official device name
- Gas Control Unit, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4300
- Medical specialty
- Cardiovascular
- Flags
- Life-sustaining
- Adverse events (MAUDE)
- 2021: 77 · 2022: 69 · 2023: 69 · 2024: 78 · 2025: 128 · 2026: 46
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Quantum Mini Ventilation Module (K210669) | Spectrum Medical , Ltd. | 2021-05-04 |
| Quantum Ventilation Module (K202733) | Spectrum Medical , Ltd. | 2020-10-16 |
| Quantum Ventilation Module (K181942) | Spectrum Medical , Ltd. | 2018-10-18 |
| STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM (K101046) | Sorin Group Deutschland GmbH | 2010-12-09 |
| SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G (K023745) | Sechrist Industries, Inc. | 2003-01-17 |
| COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) (K965214) | Coeur Laboratories, Inc. | 1997-03-28 |
| MODIFIED SARNS MEMBRANE OXYGENATOR (K863902) | 3M Health Care, Sarns | 1986-12-11 |
| GAS-FLOW METER GFL 10 (K822820) | Gambro, Inc. | 1982-10-18 |
| STANICOR, OMNI-STAN,MOD 333B,334A GAMMA (K792348) | Cordis Corp. | 1979-12-05 |
| FLOWMETER, OPTIFLO GAS (K790546) | Cobe Laboratories, Inc. | 1979-05-11 |
Track DTX automatically
Every clearance here is in the API, with alerts when new ones post.