# K061023: Thermosuit System

- Pathway: 510(k) (Traditional)
- Applicant: Life Recovery Systems Hd, LLC
- Decided: Sep 20, 2006 after 160 days
- Product code: NZE (Hyperthermia Monitor)
- 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 K912051 (1991). 1 ancestor in all.
18 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912051: Medi-Therm (Mta-5900) & Detachable Hoses, Gaymar Industries, Inc. (1991) Summary page 1.

## Most influential descendants
- K070112: Rapidcool Patient Temperature Management System (2007), 11 descendants of its own
- K100585: Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900 (2011), 9 descendants of its own
- K100071: Emcoolspad (2010), 6 descendants of its own
- K142702: Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad (2014), 4 descendants of its own
- K152266: Altrix Precision Temperature Management System (2016), 3 descendants of its own

## Recalls of this device
- Oct 21, 2011 · Not classified · Z-0456-2012: ThermoSuit System Model TSP-50 Pump/Controller may have corrosion on the temperature circuit board which may result in incorrect patient temperature reading.

## Indications for use
The ThermoSuit System TM is a thermal regulating system. Indications for Use are a. Temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients; b. Monitoring of patient temperature. The ThermoSuit System TM (Size M)is indicated for patients * greater than 58" (147 cm) and less than 75" (190 cm) in height * and less than 26" (66 cm) in width.

Source page: https://510kreport.com/device/K061023
Methodology: https://510kreport.com/methodology