# Cincinnati Sub-Zero Products, Inc.

- Location (FDA's records): Sharonville, OH
- FDA decisions: 12 (1991–2013): 12 510(k) clearances
- Product codes: DWJ (9), DWC (1), BZT (1), FLL (1)
- Predicates its devices cite: 19 (8 its own); citations of its devices by later devices: 13 (8 its own)
- Recalls linked to its devices: 22 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sims Level 1, Inc.: 2 (https://510kreport.com/company/sims-level-1)
- Respiratory Support Products, Inc.: 2 (https://510kreport.com/company/respiratory-support-products)
- Cincinnati Sub-Zero: 1 (https://510kreport.com/company/cincinnati-sub-zero)
- Jostra AG: 1 (https://510kreport.com/company/jostra)
- Seabrook Medical Systems, Inc.: 1 (https://510kreport.com/company/seabrook-medical-systems)
- Smiths Medical Asd, Inc.: 1 (https://510kreport.com/company/smiths-medical-asd)
- Augustine Medical, Inc.: 1 (https://510kreport.com/company/augustine-medical)
- Gaymar Industries, Inc.: 1 (https://510kreport.com/company/gaymar-industries)

## Firms that cite its devices most
- The Surgical Company International B.V.: 2 (https://510kreport.com/company/surgical-company-international)
- Techmedic Development International B.V.: 1 (https://510kreport.com/company/techmedic-development-international)
- Medivance, Inc.: 1 (https://510kreport.com/company/medivance)
- Welkins, LLC: 1 (https://510kreport.com/company/welkins)

## Its most-cited devices
- K101589: Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia Systems (2010), cited by 3
- K942790: Warm Air Hypertheermia System (Models #130 and #133) (1995), cited by 2
- K101148: Warm Air Model 135 Hyperthermia System and Blankets (2010), cited by 2
- K942599: Warm Air Warming Unit (1995), cited by 2
- K110104: Blanketrol II Hyper-Hypothermia Temperature Managment System (2011), cited by 1
- K072621: Esophageal/Rectal Temperature Probe and Esophageal Stethoscope with Temperature Sensor (2007), cited by 1

## Recent decisions
- K123946: Warmair Model 135 Hyperthermia System Including Filteredflo Blankets (Jan 17, 2013)
- K122813: Hemotherm Model 400CE Cooler/Heater System (Dec 18, 2012)
- K121669: Warmair Model 135 Hyperthermia System (Controller and Blankets) (Jul 3, 2012)
- K120081: Norm-O-Temp Hyperthermia System Incliding Blankets/Pads (Feb 17, 2012)
- K110104: Blanketrol II Hyper-Hypothermia Temperature Managment System (Feb 4, 2011)
- K101148: Warm Air Model 135 Hyperthermia System and Blankets (Oct 1, 2010)
- K101589: Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia Systems (Sep 20, 2010)
- K072621: Esophageal/Rectal Temperature Probe and Esophageal Stethoscope with Temperature Sensor (Dec 13, 2007)

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