# K040632: Snuggle Warm 4000 Convective Warming System, Model SW4000

- Pathway: 510(k) (Special)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Apr 27, 2004 after 48 days
- Product code: DWJ (System, Thermal Regulating)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 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)
- None. The FDA summary names its predicate without a number.
- (no number) Snuggle Warm® 4000 Convective Warming System that includes non-sterile Convective Warming Blankets (Model SW4000): named in the summary without a submission number

## Most influential descendants
- K101148: Warm Air Model 135 Hyperthermia System and Blankets (2010), 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
- K121669: Warmair Model 135 Hyperthermia System (Controller and Blankets) (2012), 1 descendant of its own
- K181699: Level 1 Convective Warmer (2018), 0 descendants of its own
- K123946: Warmair Model 135 Hyperthermia System Including Filteredflo Blankets (2013), 0 descendants of its own

## Recalls of this device
- Apr 22, 2014 · Class II · Z-1650-2014: The hose could separate from the blanket.

## Indications for use
The device is intended for thermal regulating a patient's temperature to prevent hypothermia by a warm air heated blanket to reduce cold discomfort during and after surgical procedures.

Source page: https://510kreport.com/device/K040632
Methodology: https://510kreport.com/methodology