Bair Paws Temperature Management System Model 850

510(k) K060865

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

6 closed

Documents

FDA record

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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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK060865	Date24 Apr 2006Cleared	StatusActive

6 recalls · FDA

2 recalls, same reason
- Terminated Z-0599-2018 FDA Class II initiated 23 Jan 2018
- Terminated Z-0598-2018 FDA Class II initiated 23 Jan 2018
Adesign change to 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and 63700, can make these blankets more susceptible to unintended occlusion of airflow resulting in limited or partial inflation during use.
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

1 jurisdiction

United States — FDA 510(k) Active

510(k)