# K133261: Medos Hilite 7000 & 7000 LT Oxygenator

- Pathway: 510(k) (Special)
- Applicant: Medos Medizintechnik AG
- Decided: Jan 9, 2014 after 78 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.
5 later devices descend from it; 2 cite 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)
- K082403: Medos Hilite Oxygenator, Model 7000 & 7000 LT, Gish Biomedical, Inc. (2009). Our reading of the summary gave K086403, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Medos Hilite 7000 & 7000 LT Oxygenator”.

## Most influential descendants
- 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
- K232926: Novalung ultimate kit (US) (2024), 0 descendants of its own

## Indications for use
The MEDOS HILITE 7000 & 7000 IT Hallow 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/K133261
Methodology: https://510kreport.com/methodology