Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GHS · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
35 daysmedian FDA review time
132 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K974805 | CO-STAT(TM) END TIDAL BREATH ANALYZER | Natus Medical, Inc. | 1998-03-11 | 78 | 0 |
| K910827 | ABL520 BLOOD GAS SYSTEM | Radiometer America, Inc. | 1991-07-09 | 132 | 0 |
| K790943 | TRISEDTA-BORATE ELECTROPHORESIS FILM AGA | Corning Medical & Scientific | 1979-06-22 | 35 | 0 |
| K771263 | RADIOMHTER OSM-2 HEMOXIMETER | The London Co. | 1977-08-03 | 23 | 0 |
| K770209 | ECOLYZER CARBOXIMETER | Iadec, Inc. | 1977-03-07 | 35 | 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