# K955046: Soft Venous Reservoir

- Pathway: 510(k) (Traditional)
- Applicant: Gish Biomedical, Inc.
- Decided: Jan 11, 1996 after 69 days
- Product code: DTN (Reservoir, Blood, 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K024065: Soft Venous Reservoir (Svrxx) with GBS Coating (2003), 2 descendants of its own
- K082082: Gish SVR Soft Venous Reservoirs with HA Coating (2009), 0 descendants of its own
- K050195: V-Bag with GBS Coating (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K955046
Methodology: https://510kreport.com/methodology