# K121720: Welkins Emt/Icu Temperature Managerment System

- Pathway: 510(k) (Traditional)
- Applicant: Welkins, LLC
- Decided: Aug 20, 2012 after 69 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 K003349 (2000). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110104: Blanketrol II Hyper-Hypothermia Temperature Managment System, Cincinnati Sub-Zero Products, Inc. (2011)
- K101092: Arctic Sun Temperature Management System, Model 5000, Medivance, Inc. (2010) Summary page 1.
- K070112: Rapidcool Patient Temperature Management System, Medcool, Inc. (2007) Summary page 1.
- K100071: Emcoolspad, Emcools Emergency Medical Cooling Systems AG (2010) Summary page 1.

## Indications for use
The WElkins EMT Temperature Management System is a thermal regulating system, indicated for temperature reduction in patients where clinically indicated. The WElkins ICU Temperature Management System is a thermal regulating system, indicated for temperature reduction in patients where clinically indicated and monitoring of patient temperature.

Source page: https://510kreport.com/device/K121720
Methodology: https://510kreport.com/methodology