Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
JID · 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) |
|---|---|---|---|---|---|
| K991371 | CARESIDE AMMONIA | Careside, Inc. | 1999-08-03 | 105 | 0 |
| K820723 | KODAK EKTACHEM CLINICAL CHEM. NH3 | Eastman Kodak Company | 1982-04-01 | 16 | 1 |
| K813366 | AMMONIA TEST | Wako Pure Chemical Industries, Ltd. | 1981-12-22 | 22 | 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