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Modification to:bair Hugger Temperature Management Systems

by Arizant Healthcare, Inc.

510(k) K053645

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

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 · Special NumberK053645 Date9 Mar 2006ClearedStatusActive

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0896-2010 FDA Unclassified (pre-2012) initiated 17 Dec 2009
    • Terminated Z-0895-2010 FDA Unclassified (pre-2012) initiated 17 Dec 2009
    • Terminated Z-0898-2010 FDA Unclassified (pre-2012) initiated 17 Dec 2009
    • Terminated Z-0897-2010 FDA Unclassified (pre-2012) initiated 17 Dec 2009

    Arizant Healthcare Inc. is initiating a nationwide voluntary recall of 100/110-volt power cords (Arizant part number 502221 Model 90024) attached to its temperature management units and pressure infusion power pack (Bair Paws Temperature Management Units: Models 850 and 875 Bair Hugger Temperature Management Units: Models 500/OR, 505 (Human & Vet.), 750 (Human & Vet) and 775 Ranger Blood/Flui

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 870.5900
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Arizant Healthcare, Inc.