Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FZQ · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
34 daysmedian FDA review time
93 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K884783 | RANEY CLIP | Alto Development Corp. | 1988-11-30 | 15 | 0 |
| K873744 | LEUKOCLIP(R) | Beiersdorf, Inc. | 1987-09-30 | 14 | 0 |
| K830704 | ONE TIME DISPOSABLE SKIN STAPLER | Acme United Corp. | 1983-04-12 | 36 | 0 |
| K830768 | DISPOSABLE SKIN STAPLER | Surgeons Choice, Inc. | 1983-04-12 | 32 | 0 |
| K822963 | SURGICAL PRODUCTS, SKIN STAPLE REMOVER | Temp-Stik Corp. | 1982-11-08 | 34 | 0 |
| K822145 | COMPLETE | Richard-Allan Medical Ind., Inc. | 1982-10-22 | 93 | 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