# K180834: Altrix Precision Temperature Management System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Medical
- Decided: Aug 10, 2018 after 133 days
- Product code: DWJ (System, Thermal Regulating)
- 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: 5 generations back to K912051 (1991). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152266: Altrix Precision Temperature Management System, Stryker Medical (2016) Summary page 4.

## Recalls of this device
- Sep 6, 2018 · Class II · Z-0235-2019: Users may experience alarm fatigue due to frequent alarming relating to patient temperature deviation beyond 0.5C while in Automatic mode. 2. Users may experience a Remove from Use code 9 (RFU 9) faul

## Indications for use
The Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal transfer devices for the application of regulating human body temperature in situations where a physician or clinician with prescription privileges determines that temperature therapy is necessary or desirable. Indications for use for the Altrix system include: a. Maintain pre-set body temperature as determined by the physician b. Maintain normal body temperature during surgical procedures c. For use in all clinical settings including coronary care units, operating, recovery and emergency departments, burn units, and medical/surgical units d. 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/K180834
Methodology: https://510kreport.com/methodology