Warm & Form, Orthopedic Materials: FDA clearances and approvals
Warm & Form, Orthopedic Materials has 24 FDA 510(k) clearances (first 1982, latest 1983), across 14 product codes in 4 review panels. Median 510(k) review time: 24 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ILZ | Accessories, Traction | 3 | 3 |
| ILH | Splint, Hand, And Components | 2 | 2 |
| ILI | Sling, Arm | 2 | 2 |
| IPX | Orthosis, Rib Fracture, Soft | 2 | 2 |
| IQJ | Splint, Clavicle | 2 | 2 |
| IQK | Orthosis, Cervical | 2 | 2 |
| ITQ | Joint, Knee, External Brace | 2 | 2 |
| KQZ | Component, Traction, Non-Invasive | 2 | 2 |
| KTD | Orthosis, Abdominal | 2 | 2 |
| HST | Apparatus, Traction, Non-Powered | 1 | 1 |
Plus 4 more product codes.
Review panels
- Physical Medicine (20)
- Orthopedic (2)
- Clinical Chemistry (1)
- Neurology (1)
Most recent Warm & Form, Orthopedic Materials 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K830245 | HEAD HALTER | ILZ | 1983-03-09 | 43 |
| K830244 | TRACTION ACCESSORIES | HST | 1983-03-09 | 43 |
| K830243 | ABDUCTION PILLOW | IOZ | 1983-03-08 | 42 |
| K830246 | CAST SHOE, CAST BOOT | JQB | 1983-02-18 | 24 |
| K823667 | CERVICAL COLLAR | IQK | 1982-12-30 | 24 |
| K823666 | UNIVERSAL WRIST SPLINT & FOREARM SPLINT | ILH | 1982-12-30 | 24 |
| K823665 | ROTATION BOOT | KNP | 1982-12-30 | 24 |
| K823664 | UNIVERSAL SLING, SLING & SWATHE | ILI | 1982-12-30 | 24 |
| K823663 | ABDOMINAL BINDER | KTD | 1982-12-30 | 24 |
| K823662 | RIB BELT (UNIVERSAL) | IPX | 1982-12-30 | 24 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Warm & Form, Orthopedic Materials.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Warm & Form, Orthopedic Materials have?
Warm & Form, Orthopedic Materials has 24 FDA 510(k) clearances (first 1982, latest 1983), across 14 product codes in 4 review panels.
How long does FDA take to clear Warm & Form, Orthopedic Materials's 510(k)s?
The median time from FDA receipt to decision across Warm & Form, Orthopedic Materials's cleared 510(k)s is 24 days.
What devices does Warm & Form, Orthopedic Materials make?
Its most frequent FDA product codes are ILZ (Accessories, Traction, 3); ILH (Splint, Hand, And Components, 2); ILI (Sling, Arm, 2).
Has Warm & Form, Orthopedic Materials had device recalls?
openFDA lists no recalls under a recalling firm name matching Warm & Form, Orthopedic Materials. Related entities may recall under other names.
Next steps
- See all 24 Warm & Form, Orthopedic Materials clearances with predicates and recalls
- Run predicate analysis for product code ILZ, Warm & Form, Orthopedic Materials's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.