# K090450: Medos Hilite Pediatric Oxygenator, Models 2800, 2400 LT

- Pathway: 510(k) (Traditional)
- Applicant: Gish Biomedical, Inc.
- Decided: Sep 18, 2009 after 210 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: 5 generations back to K915573 (1992). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051997: Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell Reservoir, Terumo Cardiovascular Systems Corp. (2005) Summary page 1.

## Most influential descendants
- K231982: Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 (2024), 0 descendants of its own
- K140177: Medos Hilite Oxygenator (2014), 0 descendants of its own

## 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. The 2800 & 2400 LT are pediatric oxygenators intended for use at blood flow rates of 0.5 to 2.8 liters per minute for the HILITE 2800 and 0.5 to 2.4 liters per minute for the HILTE 2400 LT for periods of up to six (6.0) hours.

Source page: https://510kreport.com/device/K090450
Methodology: https://510kreport.com/methodology