# K100585: Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900

- Pathway: 510(k) (Traditional)
- Applicant: Gaymar Industries, Inc.
- Decided: Jan 20, 2011 after 324 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: 3 generations back to K912051 (1991). 9 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 19 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.
- K070112: Rapidcool Patient Temperature Management System, Medcool, Inc. (2007) Summary page 1.
- K071341: Modification to Arctic Sun Temperature Management System, Model 2000, Medivance, Inc. (2007) Summary page 1.
- K083662: Criticool, Mtre Advanced Technology, Ltd. (2009) Summary page 1.
- K003349: Allon 2001 Modified, Mtre Advanced Technology, Ltd. (2000) Summary page 1.

## Most influential descendants
- 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
- K161602: Arctic Sun Temperature Management System (2016), 3 descendants of its own
- K200225: Arctic Sun Stat Temperature Management System (2020), 1 descendant of its own
- K251974: Arctic Sun Temperature Management System (Model 5000) (2025), 0 descendants of its own

## Indications for use
The Medi-Therm is intended for use in supplying warm or cold water at controlled temperatures via water circulating blankets or body wraps for the application of regulating patient temperature in situations where a physician determines that temperature therapy is necessary and desirable. Indications for use for the Medi-Therm thermal regulating system include: a. To maintain pre-set body temperature as determined by the physician b. To maintain normal body temperature during surgical procedures c. For use in all hospital areas including invasive and coronary care units, in operating, recovery and emergency rooms, in burn units and on medical/surgical floors d. This system can be used with adult and pediatric patients e. Monitoring and controlling patient temperature f. Temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients

Source page: https://510kreport.com/device/K100585
Methodology: https://510kreport.com/methodology