# K820297: WM. Harvey Overpressure Safety Valve

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Mar 12, 1982 after 36 days
- Product code: DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4290
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K982406: Cobe Vacuum Relief Check Valve (1998), 0 descendants of its own
- K964391: Chase Left Vent Safety Valve (1997), 0 descendants of its own

## Recalls of this device
- Jun 27, 2017 · Class II · Z-0256-2018: Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve.
- Jun 27, 2017 · Class II · Z-0257-2018: Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve.
- May 6, 2015 · Class II · Z-1828-2015: The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. There is a remote poss
- Jun 4, 2013 · Class II · Z-0603-2014: Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit.

Source page: https://510kreport.com/device/K820297
Methodology: https://510kreport.com/methodology