# K101589: Blanketrol Iii, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia Systems

- Pathway: 510(k) (Traditional)
- Applicant: Cincinnati Sub-Zero Products, Inc.
- Decided: Sep 20, 2010 after 105 days
- Product code: DWJ (System, Thermal Regulating)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003349 (2000). 7 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912051: Medi-Therm (Mta-5900) & Detachable Hoses, Gaymar Industries, Inc. (1991) Summary page 1.
- K083662: Criticool, Mtre Advanced Technology, Ltd. (2009) Summary page 1.
- (no number) Cincinnati Sub-Zero Blanketrol Hyper-Hypothermia System, Model 200: named in the summary without a submission number

## Most influential descendants
- K110104: Blanketrol II Hyper-Hypothermia Temperature Managment System (2011), 1 descendant of its own
- K122813: Hemotherm Model 400CE Cooler/Heater System (2012), 0 descendants of its own
- K121720: Welkins Emt/Icu Temperature Managerment System (2012), 0 descendants of its own
- K120081: Norm-O-Temp Hyperthermia System Incliding Blankets/Pads (2012), 0 descendants of its own

## Recalls of this device
- Jul 13, 2026 · Class II · Z-2969-2026: 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 13, 2026 · Class II · Z-2970-2026: 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-0419-2020: 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
- Jul 2, 2019 · Class II · Z-0417-2020: 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
- Sep 3, 2013 · Class II · Z-2209-2013: During a label review it was discovered that both the Blanketrol III Operations (57201-N) & Operations & Technical (56201-Q) manuals had verbiage added back into the manual during ECN M111-4260 (relea
- Oct 18, 2010 · Not classified · Z-1817-2011: The firm initiated this recall due to changes that have been made to the Blanketrol III Model 233 device's Operation and Operation/Technical Service Manuals, in order to stay in compliance with labeli

## Indications for use
The Blanketrol III Model 233 and CoolBlue Model 25-01 Hyper-Hypothermia Temperature Management Systems are 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/K101589
Methodology: https://510kreport.com/methodology