Lifemotion Disposable Membrane Oxygenator— 510(k) K253838
Substantially EquivalentLifemotion Medical Technology Co., Ltd.
FDA 510(k) clearance K253838 for Lifemotion Disposable Membrane Oxygenator, Substantially Equivalent on 2026-03-16. Applicant: Lifemotion Medical Technology Co., Ltd.. Device class: 2.
Summary
Lifemotion Medical Technology's Lifemotion Disposable Membrane Oxygenator is filed under DTZ, cardiopulmonary bypass oxygenators. The record doesn't list sizes or models.
Class II, 21 CFR 870.4350. Cardiovascular is both the classification panel and the review panel. It was a Traditional 510(k).
Lifemotion Medical Technology filed from Shenzhen, China. The decision came 105 calendar days after receipt (December 1, 2025 to March 16, 2026).
Clearance details
- Applicant
- Lifemotion Medical Technology Co., Ltd.
- Product code
- Product code DTZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.4350
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code DTZ
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- K240934 — Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3) +2 more
- K250821 — Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300) +2 more
- K242503 — Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)
- K231982 — Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2
Adverse events under product code DTZ
product code DTZ- Death
- 182
- Injury
- 422
- Malfunction
- 3,636
- Total
- 4,240
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.