# Cincinnati Sub-Zero

- Location (FDA's records): Walker, MI
- FDA decisions: 2 (1981–1981): 2 510(k) clearances
- Product codes: DWJ (2)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 6 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Innercool Therapies: 1 (https://510kreport.com/company/innercool-therapies)
- Medcool, Inc.: 1 (https://510kreport.com/company/medcool)
- Medivance, Inc.: 1 (https://510kreport.com/company/medivance)
- Cincinnati Sub-Zero Products, Inc.: 1 (https://510kreport.com/company/cincinnati-sub-zero-products)
- Radiant Medical: 1 (https://510kreport.com/company/radiant-medical)
- Sorin Group Deutschland GmbH: 1 (https://510kreport.com/company/sorin-group-deutschland)

## Its most-cited devices
- K811742: Hemotherm Model 400 (1981), cited by 5
- K811743: Maxitherm (1981), cited by 1

## Recent decisions
- K811742: Hemotherm Model 400 (Aug 13, 1981)
- K811743: Maxitherm (Jul 16, 1981)

Source page: https://510kreport.com/company/cincinnati-sub-zero