SMART M-CELL Bone Marrow Concentration System— 510(k) K250518
Substantially EquivalentMiracell Co., Ltd.
FDA 510(k) clearance K250518 for SMART M-CELL Bone Marrow Concentration System, Substantially Equivalent on 2026-04-02. Applicant: Miracell Co., Ltd.. Device class: 1.
Summary
Miracell's SMART M-CELL Bone Marrow Concentration System is filed under product code QBV (Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate).
Class I, 21 CFR 862.2050. The Hematology review panel handled it as a Traditional 510(k), though the record lists Clinical Chemistry as the classification panel.
Miracell filed from Seoul, South Korea. The decision came 405 calendar days after FDA received it (February 21, 2025 to April 2, 2026).
Clearance details
- Applicant
- Miracell Co., Ltd.
- Product code
- Product code QBV
- Device class
- Class 1
- Regulation
- 21 CFR 862.2050
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
Recent devices under product code QBV
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