# K082403: Medos Hilite Oxygenator, Model 7000 & 7000 LT

- Pathway: 510(k) (Traditional)
- Applicant: Gish Biomedical, Inc.
- Decided: May 15, 2009 after 267 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: 2 generations back to K922933 (1992). 3 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 10 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
- K133261: Medos Hilite 7000 & 7000 LT Oxygenator (2014), 5 descendants of its own
- K191407: Novalung System (2020), 3 descendants of its own
- K240880: VitalFlow Set with Balance Biosurface (2024), 1 descendant of its own
- K261335: VitalFlow Set with Balance™ Biosurface (2026), 0 descendants of its own
- K253838: Lifemotion Disposable Membrane Oxygenator (2026), 0 descendants of its own

## Indications for use
The MEDOS HILITE 7000 & 7000 LT Hollow Fiber 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 a blood flow rate of one (1.0) to seven (7.0) liters per minute for periods of up to six (6.0) hours.

Source page: https://510kreport.com/device/K082403
Methodology: https://510kreport.com/methodology