# K033021: Kimberly-Clark Patient Warming System - Model 100 Control Unit and Energy Transfer Pads

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corp.
- Decided: Nov 12, 2003 after 47 days
- Product code: DWJ (System, Thermal Regulating)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002577 (2000). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002577: Arctic Sun Temperature Management System, Model 100 Control Unit and Patient Energy Transfer Pads, Medivance, Inc. (2000) Summary page 1.

## Most influential descendants
- K062794: PRN Thermalcare, Model 3000 (2006), 2 descendants of its own
- K113705: Pintler Patient Warming System (2012), 0 descendants of its own
- K080763: Tablegard Pressure Relieving Patient Warming Mattress, Model: TG 700 HT (2008), 0 descendants of its own

## Recalls of this device
- Apr 27, 2012 · Class II · Z-2181-2012: A defect of the "fuse holder" can lead to a Control Unit failure that may cause the device to lose its ability to warm and maintain set temperature and may also result in excessive heat with the fuse 
- Sep 16, 2010 · Class II · Z-0451-2013: Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately.

## Indications for use
The KIMBERLY-CLARK* Patient Warming System is intended for monitoring and controlling patient temperature. The indications for use of the device include any condition where patient temperature control within the range covering mild hypothermia to normot6efmia is required.

Source page: https://510kreport.com/device/K033021
Methodology: https://510kreport.com/methodology