# K961425: Bio Compression Cold Flo, Single Chamber Intermittent and Multi-Chamber Sequential Models

- Pathway: 510(k) (Traditional)
- Applicant: Bio Compression Systems, Inc.
- Decided: Oct 28, 1996 after 199 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 K921540 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921540: Cooling/Heating Therapy Device, Tempacure Home Care (1992) Summary page 1.
- (no number) Jobst Cryo/Temp™: named in the summary without a submission number
- (no number) Sequential Circulator: named in the summary without a submission number

## Indications for use
The COLDFLO™ models combine cold and compression therapies. This combination is intended to provide a temporary increase in the circulation of fluids from the treated limb, reducing minor pain and swelling. The device may also enhance healing secondary to the reduction of swelling in the limb.

Source page: https://510kreport.com/device/K961425
Methodology: https://510kreport.com/methodology