# K912051: Medi-Therm (Mta-5900) & Detachable Hoses

- Pathway: 510(k) (Traditional)
- Applicant: Gaymar Industries, Inc.
- Decided: Jul 30, 1991 after 82 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
No predicates in its family tree.
46 later devices descend from it; 5 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K071341: Modification to Arctic Sun Temperature Management System, Model 2000 (2007), 20 descendants of its own
- K061023: Thermosuit System (2006), 18 descendants of its own
- K083662: Criticool (2009), 16 descendants of its own
- K022366: Celsius Control System (2003), 16 descendants of its own
- K030421: Alsius Coolgard 3000 & Alsius Catheter System (2003), 15 descendants of its own

## Recalls of this device
- Mar 29, 2017 · Class II · Z-2058-2017: The water may reheat too quickly if the unit is in "Automatic" mode, switched to "Manual" mode to view water temperature, and then switched back to "Automatic" mode.
- Dec 27, 2013 · Class II · Z-0933-2014: Stryker Medical has identified that on some units of the MTA7900, there is a lack of a water temperature display while the unit is in Auto mode. While in Auto mode, only the patient temperature is dis

Source page: https://510kreport.com/device/K912051
Methodology: https://510kreport.com/methodology