Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HRR · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
37 daysmedian FDA review time
63 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K890212 | MICROSURGICAL SCISSORS | Kinetic Medical Products | 1989-01-27 | 9 | 0 |
| K890225 | SURGICAL SCISSORS | Kinetic Medical Products | 1989-01-27 | 9 | 0 |
| K890261 | TRIGEMINAL SCISSORS | Kinetic Medical Products | 1989-01-27 | 9 | 0 |
| K873501 | SCISSOR, LEFT | Arthropedics, Inc. | 1987-11-02 | 63 | 0 |
| K873502 | SCISSOR, RIGHT | Arthropedics, Inc. | 1987-11-02 | 63 | 0 |
| K851800 | 69-100 TO 69-114 VARIOUS CUTICLE SCISSORS | Artiberia | 1985-06-20 | 56 | 0 |
| K842953 | ALL-HANDS MEDICAL SUPPLY SUTURE REMOVAL | All-Hands Medical Supply, Inc. | 1984-08-21 | 25 | 0 |
| K800721 | GENERAL UTILITY SURG. SCISSORS #460180- | Edward Weck, Inc. | 1980-05-08 | 37 | 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