Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ILH — Predicate Candidate Screening
36 FDA 510(k) clearances under this product code; the 50 most recent screened below.
18 daysmedian FDA review time
46 days90th percentile
36clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K832144 | SPLINT WOOD | Vermont Wood Industries, Inc. | 1983-08-01 | 32 | 0 |
| K831548 | SPLINTS | Fred Sammons, Inc. | 1983-06-27 | 46 | 0 |
| K823647 | FINGER EXTENSION SPLINT | Fred Sammons, Inc. | 1983-01-21 | 46 | 0 |
| K823644 | FINGER FLEXION SPLINT | Fred Sammons, Inc. | 1983-01-21 | 46 | 0 |
| K823666 | UNIVERSAL WRIST SPLINT & FOREARM SPLINT | Warm & Form, Orthopedic Materials | 1982-12-30 | 24 | 0 |
| K823601 | WRIST SUPPORT | Fred Sammons, Inc. | 1982-12-22 | 16 | 0 |
| K823393 | STAX FINGER SPLINTS | Orthopedic Systems, Inc. | 1982-12-03 | 21 | 0 |
| K823165 | WRIST SPLING & FOREARM SPLINT | Warm & Form, Orthopedic Materials | 1982-11-16 | 22 | 0 |
| K822651 | TOTAL FINGER FLEXION SPLINT | Alimed, Inc. | 1982-09-17 | 15 | 0 |
| K821637 | WIRE-FOAM MP FLEXION SPRING | Fred Sammons, Inc. | 1982-06-11 | 8 | 0 |
| K821635 | SOFT ULNAR DEVIATION SPLINTS | Fred Sammons, Inc. | 1982-06-11 | 8 | 0 |
| K820826 | STAX FINGER SPLINT | Conco Medical Co. | 1982-04-08 | 13 | 0 |
| K820381 | FINGER PROTECTOR | Conco Medical Co. | 1982-03-01 | 20 | 0 |
| K820380 | CURVED FINGER SPLINT | Conco Medical Co. | 1982-03-01 | 20 | 0 |
| K820382 | FROG SPLINT | Conco Medical Co. | 1982-03-01 | 20 | 0 |
| K820383 | FINGER COT | Conco Medical Co. | 1982-02-24 | 15 | 0 |
| K812654 | VELCRO FINGER/TOE SPLINT | Maddak, Inc. | 1981-09-25 | 8 | 0 |
| K812655 | VELCRO SPLINT STRAP FASTENERS | Maddak, Inc. | 1981-09-25 | 8 | 0 |
| K812349 | HAND SPLINTS & COMPONENTS | Fred Sammons, Inc. | 1981-09-11 | 24 | 0 |
| K810442 | HAND SPLINTS AND COMPONENTS | Fred Sammons, Inc. | 1981-03-04 | 13 | 0 |
| K810109 | METAL SPLINTS | Secol Co. | 1981-01-26 | 10 | 0 |
| K801707 | BK-1499 KAY-KPLINT HAND CONE/BK-1500 | Fred Sammons, Inc. | 1980-08-20 | 27 | 0 |
| K801714 | TRANS DISTAL JOINT FINGER EXTEN. SPLINT | Fred Sammons, Inc. | 1980-08-07 | 14 | 0 |
| K800143 | DYNAMIC EXTENSOR SPLINT | Biomet, Inc. | 1980-02-19 | 29 | 0 |
| K790182 | 2 VELCRO SPLINT STRAP | Fred Sammons, Inc. | 1979-02-15 | 20 | 0 |
| K790181 | SOFT SPLINT STRAPS | Fred Sammons, Inc. | 1979-02-13 | 18 | 0 |
| K790180 | PLATFORM SPLINTS | Fred Sammons, Inc. | 1979-02-13 | 18 | 0 |
| K772416 | PRE-FORMED SPLINT BLANKS | Fred Sammons, Inc. | 1978-01-05 | 9 | 0 |
| K772411 | PLATFORM SPLINTS | Fred Sammons, Inc. | 1978-01-05 | 9 | 0 |
| K772410 | RESTING PAN SPLINTS | Fred Sammons, Inc. | 1978-01-05 | 9 | 0 |
| K770786 | SPLINTS, FINGER/TOE | Depuy, Inc. | 1977-05-18 | 16 | 0 |
| K761131 | SAFETY PIN SPLINT | Fred Sammons, Inc. | 1976-12-02 | 13 | 0 |
| K761134 | PLASTIC FINGER CUFFS | Fred Sammons, Inc. | 1976-12-02 | 13 | 0 |
| K760299 | STRIP, CLOSED CELL FOAM, BK-7171 | Fred Sammons, Inc. | 1976-09-08 | 47 | 0 |
| K760300 | PADDING, TEMPER STICK FOAM, BK-7175 | Fred Sammons, Inc. | 1976-09-08 | 47 | 0 |
| K760298 | SUPPORT, WRIST, FIRM WIRE-FOAM | Fred Sammons, Inc. | 1976-09-08 | 47 | 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