Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Warm & Form, Orthopedic Materials — Predicate Candidate Screening
24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
24 daysmedian FDA review time
42 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K830244 | TRACTION ACCESSORIES | Warm & Form, Orthopedic Materials | 1983-03-09 | 43 | 0 |
| K830245 | HEAD HALTER | Warm & Form, Orthopedic Materials | 1983-03-09 | 43 | 0 |
| K830243 | ABDUCTION PILLOW | Warm & Form, Orthopedic Materials | 1983-03-08 | 42 | 0 |
| K830246 | CAST SHOE, CAST BOOT | Warm & Form, Orthopedic Materials | 1983-02-18 | 24 | 0 |
| K823664 | UNIVERSAL SLING, SLING & SWATHE | Warm & Form, Orthopedic Materials | 1982-12-30 | 24 | 0 |
| K823665 | ROTATION BOOT | Warm & Form, Orthopedic Materials | 1982-12-30 | 24 | 0 |
| K823662 | RIB BELT (UNIVERSAL) | Warm & Form, Orthopedic Materials | 1982-12-30 | 24 | 0 |
| K823660 | UNIVERSAL BUCKS TRACTION | Warm & Form, Orthopedic Materials | 1982-12-30 | 24 | 0 |
| K823663 | ABDOMINAL BINDER | Warm & Form, Orthopedic Materials | 1982-12-30 | 24 | 0 |
| K823667 | CERVICAL COLLAR | Warm & Form, Orthopedic Materials | 1982-12-30 | 24 | 0 |
| K823661 | CLAVICLE SUPPORT | Warm & Form, Orthopedic Materials | 1982-12-30 | 24 | 0 |
| K823659 | PELVIC TRACTION BELT | Warm & Form, Orthopedic Materials | 1982-12-30 | 24 | 0 |
| K823658 | DELUXE KNEE IMMOBILIZER(UNIVERSAL) | Warm & Form, Orthopedic Materials | 1982-12-30 | 24 | 0 |
| K823666 | UNIVERSAL WRIST SPLINT & FOREARM SPLINT | Warm & Form, Orthopedic Materials | 1982-12-30 | 24 | 0 |
| K823165 | WRIST SPLING & FOREARM SPLINT | Warm & Form, Orthopedic Materials | 1982-11-16 | 22 | 0 |
| K823164 | ABDOMINAL BINDER | Warm & Form, Orthopedic Materials | 1982-11-16 | 22 | 0 |
| K823163 | UNIVERSAL BUCKS TRACTION | Warm & Form, Orthopedic Materials | 1982-11-10 | 16 | 0 |
| K823166 | PELVIC TRACTION BELT | Warm & Form, Orthopedic Materials | 1982-11-10 | 16 | 0 |
| K823161 | CERVICAL COLLAR | Warm & Form, Orthopedic Materials | 1982-11-10 | 16 | 0 |
| K823162 | UNIVERSAL SLING, SLING & SWATHE | Warm & Form, Orthopedic Materials | 1982-11-10 | 16 | 0 |
| K823159 | DELUXE KNEE IMMOBILIZER | Warm & Form, Orthopedic Materials | 1982-11-10 | 16 | 0 |
| K823157 | CLAVICLE SUPPORT | Warm & Form, Orthopedic Materials | 1982-11-10 | 16 | 0 |
| K823160 | ROTATION BOOT | Warm & Form, Orthopedic Materials | 1982-11-10 | 16 | 0 |
| K823158 | RIB BELT (UNIVERSAL) | Warm & Form, Orthopedic Materials | 1982-11-10 | 16 | 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