# K843146: Micro-Temp Pumps & Micro-Temp Pads

- Pathway: 510(k) (Traditional)
- Applicant: Seabrook Medical Systems, Inc.
- Decided: Aug 17, 1984 after 7 days
- Product code: ILO (Pack, Hot Or Cold, Water Circulating)
- Device class: 2
- Regulation: 21 CFR 890.5720
- Recalls of this device: 2 (0 Class I)
- 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; 1 cites 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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K963293: Augustine Medical Wound Care System Model 68XXX (1997), 1 descendant of its own
- K020077: Modification to Augustine Medical Wound Care System, Model 68XXX (2002), 0 descendants of its own

## Recalls of this device
- Jan 7, 2015 · Class II · Z-1129-2015: Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak.
- Jan 18, 2005 · Not classified · Z-0671-05: There is the potential that the power switch assembly can dislodge from the cabinet during use.

Source page: https://510kreport.com/device/K843146
Methodology: https://510kreport.com/methodology