510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K250516Substantially Equivalent

SMART M-CELL PRP Concentration System

Miracell Co.,Ltd., Seoul, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250516 is the FDA 510(k) clearance record for SMART M-CELL PRP Concentration System, a class I device, cleared for Miracell Co., Ltd. on under FDA product code QBV (Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate). FDA's definition for product code QBV reads: "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...". FDA records list 2 510(k) clearances for Miracell Co., Ltd. As of , FDA records show no recalls naming K250516.

Clearance record

Decision date
Received
(405 days to decision)
Product code
QBV Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate
Regulation
21 CFR 862.2050
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Miracell Co., Ltd. Rm. 405, 474 Dunchon-Daero, Jungwon-Gu, Seoul, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QBV

Trailing 12 months
2 clearances under product code QBV in the twelve months to October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code QBV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20262
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260