Lifemotion Medical Technology Co., Ltd. · Class II · Cleared Mar 16, 2026
| K-number | K253838 |
| Device name | Lifemotion Disposable Membrane Oxygenator |
| Applicant | Lifemotion Medical Technology Co., Ltd. |
| Product code | DTZ |
| Device class | Class II |
| Decision date | Mar 16, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.4350 |
The Lifemotion Disposable Membrane Oxygenator is a single-use, sterile device for cardiopulmonary bypass surgery that performs extracorporeal oxygenation and carbon dioxide removal from blood using hollow fiber membranes. It includes an integrated heat exchanger and is designed to operate at blood flow rates of 0.5 to 7.0 liters per minute for up to six hours.
The device features hollow fiber membranes with 2.0 m² effective surface area, a heat exchanger, single gas pathway, and cylindrical geometry—all matching the predicate MEDOS Hilite 7000 & 7000 LT. The main differences are a slightly larger membrane surface area (2.0 m² vs. 1.9 m²) and a broader blood flow range (0.5–7.0 Lpm vs. 1.0–7.0 Lpm), both considered similar rather than equivalent.
Biocompatibility testing per ISO 10993-1:2018 for circulating blood contact less than 24 hours; performance testing per the FDA Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions (November 13, 2000), including gas transfer, blood and gas path integrity, blood cell damage, pressure drop, heat exchanger performance, coating integrity, and shelf life.
View the full FDA submission: accessdata.fda.gov