# K920581: Polar Pad (Sterile)

- Pathway: 510(k) (Traditional)
- Applicant: Breg, Inc.
- Decided: Mar 20, 1992 after 39 days
- Product code: ILO (Pack, Hot Or Cold, Water Circulating)
- Device class: 2
- Regulation: 21 CFR 890.5720
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K955529: Crytron System (1996), 0 descendants of its own

## Recalls of this device
- Jan 14, 2013 · Class II · Z-0804-2013: The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained damage to the product packaging which may c

Source page: https://510kreport.com/device/K920581
Methodology: https://510kreport.com/methodology