Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DTX — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
65 daysmedian FDA review time
239 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210669 | Quantum Mini Ventilation Module | Spectrum Medical , Ltd. | 2021-05-04 | 60 | 0 |
| K202733 | Quantum Ventilation Module | Spectrum Medical , Ltd. | 2020-10-16 | 28 | 0 |
| K181942 | Quantum Ventilation Module | Spectrum Medical , Ltd. | 2018-10-18 | 90 | 0 |
| K101046 | STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM | Sorin Group Deutschland GmbH | 2010-12-09 | 239 | 0 |
| K023745 | SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G | Sechrist Industries, Inc. | 2003-01-17 | 71 | 0 |
| K965214 | COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) | Coeur Laboratories, Inc. | 1997-03-28 | 88 | 0 |
| K863902 | MODIFIED SARNS MEMBRANE OXYGENATOR | 3M Health Care, Sarns | 1986-12-11 | 65 | 0 |
| K822820 | GAS-FLOW METER GFL 10 | Gambro, Inc. | 1982-10-18 | 28 | 0 |
| K792348 | STANICOR, OMNI-STAN,MOD 333B,334A GAMMA | Cordis Corp. | 1979-12-05 | 16 | 0 |
| K790546 | FLOWMETER, OPTIFLO GAS | Cobe Laboratories, Inc. | 1979-05-11 | 52 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda