# K011907: Snuggle Warm 4000 Convective Warming System

- Pathway: 510(k) (Traditional)
- Applicant: Sims Level 1, Inc.
- Decided: Dec 18, 2001 after 183 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
Longest line of descent: 1 generation back to K904690 (1991). 1 ancestor in all.
8 later devices descend from it; 5 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904690: Temp Marq (TM) Convective Warming System, Marquest Medical Products, Inc. (1991) Summary page 1.

## Most influential descendants
- K061513: Level 1 Snuggle Warm Pediatric and Large Pediatric Underbody Blanket (2006), 3 descendants of its own
- K101148: Warm Air Model 135 Hyperthermia System and Blankets (2010), 2 descendants of its own
- 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
- K121669: Warmair Model 135 Hyperthermia System (Controller and Blankets) (2012), 1 descendant of its own

## Recalls of this device
- Dec 15, 2004 · Not classified · Z-0497-05: Warmer heater coil may come in contact with the filter housing, causing a small area of the plastic housing to melt

## Indications for use
The Snuggle Warm 4000 Convective Warming System is intended for thermal regulating a patient’s temperature to prevent hypothermia by a warm air heated blanket system (o 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/K011907
Methodology: https://510kreport.com/methodology