# K915196: Incare Hot/Ice System 3

- Pathway: 510(k) (Traditional)
- Applicant: Hollister, Inc.
- Decided: Feb 3, 1992 after 76 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K962537: Incare Hot/Ice Lite Machine (1996), 0 descendants of its own
- K955529: Crytron System (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K915196
Methodology: https://510kreport.com/methodology