Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FYH — Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
55 daysmedian FDA review time
218 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K925145 | TRACE MODEL #'S 840, 841, 842, 845 | Trace Medical Equipment, Inc. | 1993-05-19 | 218 | 0 |
| K924984 | SPECIALIST(R) WALKER | Johnson & Johnson Orthopaedics, Inc. | 1993-02-01 | 123 | 0 |
| K895092 | KUT-SHIELD | Kut-Guard, Inc. | 1989-09-26 | 43 | 0 |
| K852558 | SPLINTS(ALL TYPE) | The Huxley Instrument Corp. | 1985-07-02 | 15 | 0 |
| K843400 | HYDRO-SPLINT A SPONGE-COMPRESS DRESS | Compression Splint Products, Inc. | 1984-10-24 | 55 | 0 |
| K821693 | J & J DIP WATER ADDITIVE | Johnson & Johnson Professionals, Inc. | 1982-07-02 | 24 | 0 |
| K802522 | DELTA-LITE CASTING TAPE & SPLINTS | Johnson & Johnson Professionals, Inc. | 1981-01-08 | 85 | 0 |
| K801436 | ORTHOPEDIC LOWER EXTREMITY SUSPENSION | Orthopedic Systems, Inc. | 1980-06-26 | 7 | 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