# K140181: Medos Hilite Infant Oxygenator

- Pathway: 510(k) (Special)
- Applicant: Medos Medizintechnik AG
- Decided: Feb 19, 2014 after 26 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 K842908 (1985). 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)
- K090449: Medos Hilite Infant Oxygenator, Model 1000, 800 LT, Gish Biomedical, Inc. (2009) Summary page 1.

## Indications for use
The MEDOS HILITE 1000 & 800 LT Infant Hollow Fiber Oxygenators are 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 200 mI/mmn (0.2 liters/minute) to iQO0mI/min (1.0 liters per minute) for the Hilite 1000 and 200 mI/mmn (0.2 liters/minute) to 800 mI/mmn (0.8 liters per minute) for the Hilite 800 LT for periods of up to six (6.0) hours.

Source page: https://510kreport.com/device/K140181
Methodology: https://510kreport.com/methodology