# K250516: SMART M-CELL PRP Concentration System

- Pathway: 510(k) (Traditional)
- Applicant: Miracell Co., Ltd.
- Decided: Apr 2, 2026 after 405 days
- Product code: QBV (Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate)
- Device class: 1
- Regulation: 21 CFR 862.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K991430 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052925: SMARTPREP2 Centrifuge System, Harvest Technologies, Corp. (2006) Summary page 5.

## Indications for use
The SMART M-CELL PRP Concentration System is indicated for use in clinical laboratories or intraoperatively at point-of-care for the safe and rapid extraction and transfer of platelet concentrate from a small volume of venous whole blood following centrifugal separation.

Source page: https://510kreport.com/device/K250516
Methodology: https://510kreport.com/methodology