Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BYR · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K896718 | BICORE VARIFLEX(R) FLOW TRANSDUCER | Bicore Monitoring Systems | 1990-02-22 | 85 | 0 |
| K801880 | MMI/GAELTEC SERIES 8T DIFF. PRESS. TRANS | Medical Measurements, Inc. | 1980-08-14 | 7 | 0 |
| K790334 | DRAGER ORM | Draeger Medical, Inc. | 1979-03-07 | 19 | 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