# K982406: Cobe Vacuum Relief Check Valve

- Pathway: 510(k) (Abbreviated)
- Applicant: Cobe Cardiovascular, Inc.
- Decided: Oct 7, 1998 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 K820297 (1982). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K820297: WM. Harvey Overpressure Safety Valve, C.R. Bard, Inc. (1982) Summary page 1.
- K861428: Suction Control Valve (Nonadjustable) Cat.RLV-2100, American Omni Medical, Inc. (1986) Summary page 1.

## Indications for use
The COBE® Vacuum Relief Check Valve is intended to be used during cardiopulmonary bypass surgery to help prevent the buildup of excessive vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent flow of air into the heart.

Source page: https://510kreport.com/device/K982406
Methodology: https://510kreport.com/methodology