Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MJD · 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) |
|---|---|---|---|---|---|
| K920143 | TB SUSCEPTIBILITY QUADS I AND II | Remel Co. | 1992-06-09 | 148 | 0 |
| K840981 | NIACIN REAGENT STRIP | Remel Co. | 1984-03-23 | 17 | 0 |
| K823859 | MIDDLEBROOK 7H10 AGAR BASE-LOWPH | Gibco Laboratories Life Technologies, Inc. | 1983-03-08 | 76 | 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