# K960937: Suction Safety Device

- Pathway: 510(k) (Traditional)
- Applicant: R D Intl.
- Decided: Jun 5, 1996 after 89 days
- Product code: MJJ (Cpb Check Valve, Retrograde Flow, In-Line)
- Device class: 2
- Regulation: 21 CFR 870.4400
- 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 K760894 (1976). 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)
- K760894: Vacuum Relief Valve, Delta Medical Industries (1976) Summary page 1.

## Indications for use
The RDI Suction Safety Device is intended to be used during open heart surgery and placed in a suction line to permit flow only away from the heart, prevent buildup of line pressure, and limit line vacuum.

Source page: https://510kreport.com/device/K960937
Methodology: https://510kreport.com/methodology