K253838 is an FDA 510(k) clearance for the Lifemotion Disposable Membrane Oxygenator. This device is classified as a Oxygenator, Cardiopulmonary Bypass (Class II - Special Controls, product code DTZ).
Submitted by Lifemotion Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 16, 2026, 105 days after receiving the submission on December 1, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4350.
| 510(k) Number | K253838 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 2025 |
| Decision Date | March 16, 2026 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTZ — Oxygenator, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4350 |