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BLANKETROL III - Model 25-01 Hyper-Hypothermia Systems

by Cincinnati Sub-Zero Products, Inc.

510(k) K101589

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK101589 Date20 Sep 2010ClearedStatusActive

Recalls

6 recalls · 2 ongoing · FDA

    • Ongoing Z-2970-2026 FDA Class II initiated 13 Jul 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,

    • Ongoing Z-2969-2026 FDA Class II initiated 13 Jul 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.

  • 2 recalls, same reason

    • Terminated Z-0419-2020 FDA Class II initiated 2 Jul 2019
    • Terminated Z-0417-2020 FDA Class II initiated 2 Jul 2019

    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 Automatic modes

    • Terminated Z-2209-2013 FDA Class II initiated 3 Sep 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 (released 12/29/2011) which was previously removed for clarification of the intended use and subsequent 501(K) approval.

    • Terminated Z-1817-2011 FDA Unclassified (pre-2012) initiated 18 Oct 2010

    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 labeling regulations.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DWJ
Models / Variants
Model 25-01 Hyper-Hypothermia Systems
Device Class
Class II
Regulation
21 CFR Part 870.5900
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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