510(k) K250516
K250516 is an FDA 510(k) premarket notification submitted by Miracell Co., Ltd. for the device "SMART M-CELL PRP Concentration System". The FDA issued a decision of Substantially Equivalent on Apr 2, 2026. The device falls under product code QBV (Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate), a Class I device regulated under 21 CFR 862.2050. Miracell Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 2, 2026
- Date Received
- Feb 21, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate
- Device Class
- Class I
- Regulation Number
- 862.2050
- Review Panel
- HE
- Submission Type
To prepare cell concentrate and/or plasma concentrate by separating cells through centrifugation. Contraindications - Labeling Warnings and Precautions: The safety and effectiveness of this device for in vivo indications for use has not been established.