# K142500: One Way Soft Valve

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corporation
- Decided: Jan 29, 2015 after 146 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 K922356 (1993). 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)
- K922356: Flow Control Valve, Cat. NO. Acv-38, American Omni Medical, Inc. (1993) Summary page 5.

## Indications for use
The One Way Soft Valve is intended to be used for the prevention of retrograde flow in ¼” or smaller lines subject to arterial pressure during cardiopulmonary bypass procedures for use up to six hours.

Source page: https://510kreport.com/device/K142500
Methodology: https://510kreport.com/methodology