510(k) K253838
K253838 is an FDA 510(k) premarket notification submitted by Lifemotion Medical Technology Co., Ltd. for the device "Lifemotion Disposable Membrane Oxygenator". The FDA issued a decision of Substantially Equivalent on March 16, 2026. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 2026
- Date Received
- December 1, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oxygenator, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4350
- Review Panel
- CV
- Submission Type