# K992964: Ibc Vent Valve, Model 1400

- Pathway: 510(k) (Traditional)
- Applicant: International Biophysics Corp.
- Decided: Nov 19, 1999 after 78 days
- Product code: MNJ (Valve, Pressure Relief, Cardiopulmonary Bypass)
- 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
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) American Omni Vent Valve: named in the summary without a submission number

## Indications for use
The Cardiotomy Vent Valve is indicated for use to maintain a low level of vacuum in cardiotomy reservoirs.

Source page: https://510kreport.com/device/K992964
Methodology: https://510kreport.com/methodology