Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BYO — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K924541 | EPIDURAL MINIPACK | Concord/Portex | 1993-07-09 | 304 | 0 |
| K913527 | HYPERFREE | Kist Intl. | 1992-01-21 | 166 | 0 |
| K780558 | BOTTLE BREATHING DEVICE | B & F Medical Products, Inc. | 1978-05-26 | 51 | 0 |
| K780407 | 2C7125 BLOW BOTTLE | Travenol Laboratories, S.A. | 1978-04-10 | 28 | 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