# K961530: Gish Reliance Oxygenator (Model Hfo)

- Pathway: 510(k) (Traditional)
- Applicant: Gish Biomedical, Inc.
- Decided: Dec 5, 1996 after 227 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K922933 (1992). 2 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923272: Cobe CMS-HF Hollow Fiber Membrane Oxygenator, Cobe Laboratories, Inc. (1993) Summary page 1.
- K922933: Sorin Monolyrh Integrated Membrane Lung, Sorin Biomedica, Fiat, USA, Inc. (1992) Summary page 1.

## Most influential descendants
- K082403: Medos Hilite Oxygenator, Model 7000 & 7000 LT (2009), 6 descendants of its own
- K133261: Medos Hilite 7000 & 7000 LT Oxygenator (2014), 5 descendants of its own
- K191407: Novalung System (2020), 3 descendants of its own
- K023381: Vision Hollow Fiber Oxygenator with Guardian Coating (2003), 2 descendants of its own
- K240880: VitalFlow Set with Balance Biosurface (2024), 1 descendant of its own

## Recalls of this device
- Mar 31, 2003 · Not classified · Z-0780-03: Two reports of leakage.

## Indications for use
The Gish Reliance™ Oxygenator is indicated for use in procedures requiring the extracorporeal oxygenation of, and carbon dioxide removal from, human blood. It is designed to operate at blood flow rates of one half (0.5) to eight (8.0) liters per minute for periods of up to six (6.0) hours.

Source page: https://510kreport.com/device/K961530
Methodology: https://510kreport.com/methodology