# K083131: Medos Hilite Reservoir, Model: 4030

- Pathway: 510(k) (Traditional)
- Applicant: Gish Biomedical, Inc.
- Decided: Jul 30, 2009 after 280 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
Longest line of descent: 2 generations back to K883923 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964973: Gish Cap VRF45 Cardiotomy/Venous Reservoir, Gish Biomedical, Inc. (1997) Summary page 1.

## Indications for use
The MEDOS HILITE MVC 4030 Hardshell Venous Reservoir is indicated for use during cardiopulmonary bypass surgery as a storage reservoir for gravity and augmented venous return blood and to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit at flow rates of one (1.0) to seven (7.0) liters per minute for periods up to six hours (6.0) hours.

Source page: https://510kreport.com/device/K083131
Methodology: https://510kreport.com/methodology