# K023381: Vision Hollow Fiber Oxygenator with Guardian Coating

- Pathway: 510(k) (Traditional)
- Applicant: Gish Biomedical, Inc.
- Decided: Mar 31, 2003 after 174 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K922933 (1992). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 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.

## Most influential descendants
- K080708: Vision Hollow Fiber Oxygenator with HA Coating (2009), 0 descendants of its own
- K031300: Ibc Flopump with GBS Coating (2003), 0 descendants of its own

## Recalls of this device
- Nov 28, 2005 · Not classified · Z-0519-06: Gish received four reports of potential leakage. All reports were associated with GBS coating. There was no patient injury reported.
- Mar 4, 2004 · Not classified · Z-0730-04: Customers reported leakage.

## Indications for use
The Vision Hollow Fiber Oxygenator with GuardianTMCoating 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.O) to eight (8.0) liters per minute for periods of up to six (6.0) hours.

Source page: https://510kreport.com/device/K023381
Methodology: https://510kreport.com/methodology