FDA Clears Miracell's SMART M-CELL Systems for Platelet and Bone Marrow Concentrates

The US Food and Drug Administration has cleared two Miracell systems for preparing platelet and bone marrow concentrates, the Seoul-based company said in an April 10 release distributed by PR Newswire, read on BioSpace.

The clearances cover the SMART M-CELL centrifuge along with its BSC Blood Kit and BMSC Bone Marrow Kit, according to the company.

Two 510(k)s, one predicate

The FDA's 510(k) database lists two separate clearances. The SMART M-CELL PRP Concentration System was cleared under K250516 and the SMART M-CELL Bone Marrow Concentration System under K250518. The agency received both on February 21, 2025, and issued substantially equivalent decisions on April 2, 2026, about 13 months later. Both fall under product code QBV, a centrifuge for preparing cell or plasma concentrate, and were reviewed by the hematology panel.

The K250516 decision summary classifies the device as Class I general purpose laboratory equipment labeled or promoted for a specific medical use. It says the PRP 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." The K250518 decision summary describes the bone marrow version as intended for "the safe and rapid preparation of a cell concentrate from bone marrow."

Both summaries carry the same limits: prescription use only, "for in vitro use only," and a statement that the safety and effectiveness of the device for in vivo indications has not been established. Both name the SmartPReP2 Centrifuge System, cleared under K052925, as the predicate device. In the PRP summary, the FDA wrote that the system is equivalent to the predicate "in preparing platelet concentrate, with comparable cell count profiles and platelet recovery rates."

The PRP system pairs a SMART M-CELL 2 or SMART M-CELL 4 centrifuge with a procedure pack. Its two-stage spin cycle runs at fixed speeds and times that the operator cannot adjust, according to the summary.

What the company claims

Miracell said the clearance validates the whole integrated system, combining centrifuge and kit, and it contrasted this with conventional centrifuge devices that it said have typically been classed as lower-risk, notification-only products. The FDA summaries list the systems as Class I devices.

The release also cites published studies of bone marrow and blood concentrates in knee osteoarthritis, rotator cuff tears and cartilage defects. Those uses are not part of the cleared indications, which cover preparing the concentrate rather than any treatment.

The company said it supplies SMART M-CELL and its kits to about 40 countries, including in Europe, that regulatory approvals are underway in Brazil and Taiwan, and that it plans to expand into the US following the clearance. It said it secured a US patent for the centrifuge container used in the kit in February 2024. No US launch date or price was given.