# K140177: Medos Hilite Oxygenator

- Pathway: 510(k) (Special)
- Applicant: Medos Medizintechnik AG
- Decided: Feb 18, 2014 after 25 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: 6 generations back to K915573 (1992). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090450: Medos Hilite Pediatric Oxygenator, Models 2800, 2400 LT, Gish Biomedical, Inc. (2009) Summary page 1.

## Indications for use
The Medos hilite 2800 & 2400 LT 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 0.5 to 2.8 liters per minute for the hilite 2800 and 0.5 to 2.4 liters per minute for the hilite 2400 LT for periods of up to six (6.0) hours.

Source page: https://510kreport.com/device/K140177
Methodology: https://510kreport.com/methodology