Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HTS — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
48 daysmedian FDA review time
386 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K930507 | CUSTOM ORTHOPAEDIC TRAYS (PACKS) | Associated Medical Products Co. | 1994-02-22 | 386 | 0 |
| K933921 | ACUFLEX DISPOSABLE KNIVES | Acufex Microsurgical, Inc. | 1994-01-26 | 169 | 0 |
| K882525 | SPINAL MICROKNIFE | Karlin Technology, Inc. | 1988-09-22 | 97 | 0 |
| K873713 | TRIANGULAR KNIFE, DISPOSABLE #TM-1611 | Arthropedics, Inc. | 1987-11-02 | 48 | 0 |
| K873714 | BANANA KNIFE, DISPOSABLE #TM-1612 | Arthropedics, Inc. | 1987-11-02 | 48 | 0 |
| K873711 | RETROGRADE KNIFE, DISPOSABLE #TM-1613 | Arthropedics, Inc. | 1987-11-02 | 48 | 0 |
| K873712 | STANDARD KNIFE, DISPOSABLE #TM-1610 | Arthropedics, Inc. | 1987-10-15 | 30 | 0 |
| K842820 | ARTHROSCOPY KNIVES | Medtech Industries, Inc. | 1984-08-14 | 26 | 0 |
| K771851 | ARTHROSCOPE OPERATIVE KNIFE SET | Richard Wolf Medical Instruments Corp. | 1977-10-27 | 28 | 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