Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HTP — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
85 daysmedian FDA review time
294 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K931733 | INTERMEDICS ORTHOPEDICS REAMERS | Intermedics Orthopedics | 1994-01-26 | 294 | 0 |
| K870842 | SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP | Warsaw Orthopedic, Inc. | 1987-05-27 | 85 | 0 |
| K862659 | CONCEPT ARTHROSCOPY RASP | Concept, Inc. | 1986-09-02 | 50 | 0 |
| K841981 | 4MM & 5MM FILE | Stainless Mfg., Inc. | 1984-06-19 | 36 | 0 |
| K840492 | SUN-LITE BLUE SLIT | Suncoast Medical Manufacturers, Inc. | 1984-05-09 | 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