# K141686: Equator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming Blanket, Snuggle Warm Pediatricfull Body

- Pathway: 510(k) (Traditional)
- Applicant: Smith Medical Asd, Inc.
- Decided: Oct 28, 2014 after 127 days
- Product code: DWJ (System, Thermal Regulating)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K873745 (1987). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011907: Snuggle Warm 4000 Convective Warming System, Sims Level 1, Inc. (2001) Summary page 9.
- K083336: Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket, Model SW-2013, Level 1 Snuggle Warm Left Lateral, Smiths Medical Asd, Inc. (2009) Summary page 9.
- K061513: Level 1 Snuggle Warm Pediatric and Large Pediatric Underbody Blanket, Smiths Medical Asd, Inc. (2006) Summary page 14.
- K040632: Snuggle Warm 4000 Convective Warming System, Model SW4000, Smiths Medical Asd, Inc. (2004) Summary page 16.
- K001149: Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750 Warming Unit, Bair Hugger Blank, Augustine Medical, Inc. (2000) Summary page 18.

## Most influential descendants
- K181699: Level 1 Convective Warmer (2018), 0 descendants of its own

## Indications for use
The Equator® Convective Warmer is intended to prevent and treat hypothermia when temperature therapy is clinically indicated. The warmer can also be used to provide thermal comfort when conditions exist that may cause patients to become too warm or too cold. The Equator® Convective Warmer can be used with adult or pediatric patients and is intended for use by appropriately trained healthcare professionals in clinical environments. The Snuggle Warm® Convective Warming Blanket is intended to prevent and treat hypothermia when temperature therapy is clinically indicated. The warming blanket can also be used to provide thermal comfort when conditions exist that may cause patients to become too warm or too cold. The Snuggle Warm® Convective Warming Blanket can be used with adult or pediatric patients and is intended for use by appropriately trained healthcare professionals in clinical environments

Source page: https://510kreport.com/device/K141686
Methodology: https://510kreport.com/methodology