# K061513: Level 1 Snuggle Warm Pediatric and Large Pediatric Underbody Blanket

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Aug 1, 2006 after 61 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: 2 generations back to K904690 (1991). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 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)

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

## Indications for use
For thermal regulation of a patient's temperature to prevent hypothermia and/or reduce cold discomfort during and after surgical procedures. It is intended for use by appropriately trained healthcare professionals in clinical environments.

Source page: https://510kreport.com/device/K061513
Methodology: https://510kreport.com/methodology