# K060865: Bair Paws Temperature Management System Model 850

- Pathway: 510(k) (Special)
- Applicant: Arizant Healthcare, Inc.
- Decided: Apr 24, 2006 after 25 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 K873745 (1987). 7 ancestors in all.
4 later devices descend from it; 2 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)
- K053645: Modification to:Bair Hugger Temperature Management Systems, Arizant Healthcare, Inc. (2006) Summary page 1.

## Most influential descendants
- K083336: Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket, Model SW-2013, Level 1 Snuggle Warm Left Lateral (2009), 2 descendants of its own
- K141686: Equator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming Blanket, Snuggle Warm Pediatricfull Body (2014), 1 descendant of its own
- K232502: Cocoon Convective Warming System, Model CWS7000 (2024), 0 descendants of its own
- K181699: Level 1 Convective Warmer (2018), 0 descendants of its own

## Recalls of this device
- Jan 23, 2018 · Class II · Z-0599-2018: 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
- Jan 23, 2018 · Class II · Z-0598-2018: 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
- Dec 17, 2009 · Not classified · Z-0897-2010: 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 infus
- Dec 17, 2009 · Not classified · Z-0898-2010: 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 infus
- Dec 17, 2009 · Not classified · Z-0895-2010: 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 infus
- Dec 17, 2009 · Not classified · Z-0896-2010: 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 infus

## Indications for use
The Bair Hugger family of temperature management systems are indicated for hyper- or hypothermic patients or normothermic patients for whom induced hyper- or hypothermia or localized temperature therapy is clinically indicated. In addition, the temperature management systems can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management systems can be used with adult and pediatric patients.

Source page: https://510kreport.com/device/K060865
Methodology: https://510kreport.com/methodology