Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LIR · 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) |
|---|---|---|---|---|---|
| K023947 | GC OIA | Thermo Biostar, Inc. | 2003-04-17 | 141 | 0 |
| K882534 | ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROL | Abbott Laboratories | 1988-07-12 | 21 | 0 |
| K881064 | HYGEIA GC TEST | Hygeia Sciences | 1988-06-02 | 80 | 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