# K110104: Blanketrol II Hyper-Hypothermia Temperature Managment System

- Pathway: 510(k) (Traditional)
- Applicant: Cincinnati Sub-Zero Products, Inc.
- Decided: Feb 4, 2011 after 22 days
- Product code: DWJ (System, Thermal Regulating)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K003349 (2000). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101589: Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia Systems, Cincinnati Sub-Zero Products, Inc. (2010) Summary page 1.

## Most influential descendants
- K121720: Welkins Emt/Icu Temperature Managerment System (2012), 0 descendants of its own

## Recalls of this device
- Jul 13, 2026 · Class II · Z-2968-2026: Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and Blanketrol II Model 222S products may cause the device to shut down.
- Jul 2, 2019 · Class II · Z-0418-2020: Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automat
- Jan 8, 2014 · Class II · Z-1679-2014: The incorrect voltage component was placed into the device during manufacturing. This may make the device unable to maintain patient temperature during cooling mode. The device will continue to indica

## Indications for use
The Blanketrol II Model 222S Hyper-Hypothermia Temperature Management System is used to lower or to raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer. The system is composed of a heater, a compressor, a circulating pump and blankets/pads.

Source page: https://510kreport.com/device/K110104
Methodology: https://510kreport.com/methodology