# K960312: Rdi Cardiac Insulation Pad

- Pathway: 510(k) (Traditional)
- Applicant: R D Intl.
- Decided: Apr 19, 1996 after 88 days
- Product code: DWP (Dilator, Vessel, Surgical)
- Device class: 2
- Regulation: 21 CFR 870.4475
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Sorin/Shiley Inc. Cardiac Insulation Pad: named in the summary without a submission number

## Indications for use
The RDI Cardiac Insulation Pad is intended to be used during open heart surgery to insulate the myocardium from the warmer organs and tissues in the body and thus reduce undesired rewarming of the heart.

Source page: https://510kreport.com/device/K960312
Methodology: https://510kreport.com/methodology