Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HQQ · 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) |
|---|---|---|---|---|---|
| K910088 | SCITECH BI-MANUAL ADAPTER CLIPS | Scitech Industries Partnership | 1991-04-08 | 89 | 0 |
| K903878 | MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT | Mentor O & O, Inc. | 1990-11-05 | 75 | 0 |
| K881001 | MENTOR WET-FIELD*II COAGULATOR | Mentor O & O, Inc. | 1988-05-13 | 65 | 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