# K253838: Lifemotion Disposable Membrane Oxygenator

- Pathway: 510(k) (Traditional)
- Applicant: Lifemotion Medical Technology Co., Ltd.
- Decided: Mar 16, 2026 after 105 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: 4 generations back to K922933 (1992). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133261: Medos Hilite 7000 & 7000 LT Oxygenator, Medos Medizintechnik AG (2014) Summary page 5.

## Indications for use
The Lifemotion Disposable Membrane Oxygenator is indicated for use in cardiopulmonary bypass surgery 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 7.0 liters per minute for periods of up to six (6.0) hours.

Source page: https://510kreport.com/device/K253838
Methodology: https://510kreport.com/methodology