Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HTX — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
28 daysmedian FDA review time
154 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K874954 | MANUAL RONGEUR | Solway, Inc. | 1987-12-30 | 28 | 0 |
| K841620 | FRONT RADIUS CUTTER | Plastafil, Inc. | 1984-09-20 | 154 | 0 |
| K841621 | BACK RADIUS CUTTER | Plastafil, Inc. | 1984-09-20 | 154 | 0 |
| K780397 | ORTHOPEDIC FORCEPS | Orthopedic Equipment Co., Inc. | 1978-03-22 | 9 | 0 |
| K760325 | SURGICAL INSTRUMENTS, ORTHOPEDIC | Depuy, Inc. | 1976-08-03 | 8 | 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