# K123946: Warmair Model 135 Hyperthermia System Including Filteredflo Blankets

- Pathway: 510(k) (Special)
- Applicant: Cincinnati Sub-Zero Products, Inc.
- Decided: Jan 17, 2013 after 27 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: 4 generations back to K904690 (1991). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101148: Warm Air Model 135 Hyperthermia System and Blankets, Cincinnati Sub-Zero Products, Inc. (2010) Summary page 2.
- K121669: Warmair Model 135 Hyperthermia System (Controller and Blankets), Cincinnati Sub-Zero Products, Inc. (2012) Summary page 1.

## Indications for use
The WarmAir®D 135 patient warming system is intended to prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures. The thermal regulating system is used to raise a patient's temperature and/or maintain a desired patient temperature through convective heat transfer from the controller to a warm-air-heated blanket. The single-patient use blankets transfer the thermal energy to adult, pediatric or neonate patients to obtain/maintain normal body temperature. It is intended for use by appropriately trained healthcare professionals in clinical environments.

Source page: https://510kreport.com/device/K123946
Methodology: https://510kreport.com/methodology