# K080708: Vision Hollow Fiber Oxygenator with HA Coating

- Pathway: 510(k) (Traditional)
- Applicant: Gish Biomedical, Inc.
- Decided: Feb 2, 2009 after 327 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K922933 (1992). 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)
- K961530: Gish Reliance Oxygenator (Model Hfo), Gish Biomedical, Inc. (1996) Summary page 1.
- K023381: Vision Hollow Fiber Oxygenator with Guardian Coating, Gish Biomedical, Inc. (2003) Summary page 1.

## Indications for use
The Vision Hollow Fiber Oxygenator with HA Coating is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of one (1.0) to eight (8.0) liters per minute for periods of up to six (6.0) hours.

Source page: https://510kreport.com/device/K080708
Methodology: https://510kreport.com/methodology