# Omni Therm, Inc.

- Location (FDA's records): St. Louis, MO
- FDA decisions: 5 (1987–1996): 5 510(k) clearances
- Product codes: IMD (4), KPD (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Mediheat, Inc.: 1 (https://510kreport.com/company/mediheat)
- Rapid Aid Corp.: 1 (https://510kreport.com/company/rapid-aid)

## Its most-cited devices
- K936084: Omni Warm Gel Packs (1994), cited by 2

## Recent decisions
- K961176: Omni Cold Gel Packs (Sep 4, 1996)
- K955788: Imni Hot Packs (Sep 4, 1996)
- K954877: Omni Cold Gel Packs (Feb 13, 1996)
- K936084: Omni Warm Gel Packs (Mar 31, 1994)
- K864853: Omni Therm Temperature Monitor (Feb 4, 1987)

Source page: https://510kreport.com/company/omni-therm