Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BYK · 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) |
|---|---|---|---|---|---|
| K941547 | CAM 4 THERMOELECTRIC CHILD/ADULT MIST TENT | Allied Healthcare Products, Inc. | 1995-03-01 | 336 | 0 |
| K882817 | LUNG DIFFUSION GAS MIXTURE | Swisco, Inc. | 1988-08-15 | 38 | 0 |
| K813235 | DISS FEMALE AIR ADAPTOR | Timeter Instrument Corp. | 1981-12-08 | 21 | 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