SMART M-CELL PRP Concentration System— 510(k) K250516
Substantially EquivalentMiracell Co., Ltd.
FDA 510(k) clearance K250516 for SMART M-CELL PRP Concentration System, Substantially Equivalent on 2026-04-02. Applicant: Miracell Co., Ltd.. Device class: 1.
Summary
Miracell's SMART M-CELL PRP Concentration System is filed under product code QBV (Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate). The record doesn't describe the system beyond its name and that code name.
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 record shows 405 calendar days from receipt to decision (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
view allData sourced from openFDA. This site is unofficial and independent of the FDA.