# K955529: Crytron System

- Pathway: 510(k) (Traditional)
- Applicant: Mark H. Friedman
- Decided: Jun 10, 1996 after 189 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 K891152 (1989). 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)
- K891152: Grand Cooling Machine, Kinetic Concepts, Inc. (1989) Summary page 2.
- K891151: Cool 'N Heat Machine, Kinetic Concepts, Inc. (1989) Summary page 2.
- K902269: Electri-Cool (TM) Liquid-Circulat. Thermal Therapy, Seabrook Medical Systems, Inc. (1990) Summary page 2.
- K920581: Polar Pad (Sterile), Breg, Inc. (1992) Summary page 2.
- K914434: Polar Pads, Breg, Inc. (1991) Summary page 2.
- K935841: DR Kool, Toronto Medical Corp. (1994) Summary page 2.
- K945067: EBICE, Electro-Biology, Inc. (1995) Summary page 2.
- K915196: Incare Hot/Ice System 3, Hollister, Inc. (1992) Summary page 2.

## Indications for use
These products have the same intended use, to cool a small portion of the body to provide temporary relief of minor aches and pains and muscle spasms or bruises.

Source page: https://510kreport.com/device/K955529
Methodology: https://510kreport.com/methodology