# K962537: Incare Hot/Ice Lite Machine

- Pathway: 510(k) (Traditional)
- Applicant: Hollister, Inc.
- Decided: Nov 27, 1996 after 152 days
- Product code: ILO (Pack, Hot Or Cold, Water Circulating)
- Device class: 2
- Regulation: 21 CFR 890.5720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K830757 (1983). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K830757: Hot/Ice, Thermo Temp, Inc. (1983) Summary page 1.
- K915196: Incare Hot/Ice System 3, Hollister, Inc. (1992) Summary page 1.

## Indications for use
The InCare HOT/ICE Lite Machine is intended to provide cold therapy to body surfaces by pumping and circulating chilled water through a plastic bag or plastic blanket that has been secured to the patient’s anatomy.

Source page: https://510kreport.com/device/K962537
Methodology: https://510kreport.com/methodology