# K992932: Cipa (Adults) Cipi (Infants)

- Pathway: 510(k) (Traditional)
- Applicant: Dmc Medical, Ltd.
- Decided: Jun 7, 2000 after 281 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- 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 K781990 (1978). 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)
- K781990: Cardiac Insulation Pad, Shiley, Inc. (1978) Summary page 1.

## Indications for use
The cardiac insulation pad is indicated for use in patients undergoing heart surgery where there is a need to reduce undesirable re-warming of the myocardium and protect the left phrenic nerve from cold injury during local cooling of the heart.

Source page: https://510kreport.com/device/K992932
Methodology: https://510kreport.com/methodology