FDA 510(k)

SMART M-CELL PRP Concentration System

K-Number: K250516 · 2026-04-02

Decision Date2026-04-02

Product CodeQBV

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

SMART M-CELL PRP Concentration System is the device name listed in this FDA 510(k) record. The listed applicant is Miracell Co., Ltd.. It received FDA 510(k) clearance on 2026-04-02 under 510(k) number K250516. The device is classified under product code QBV. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMART M-CELL PRP Concentration System?

SMART M-CELL PRP Concentration System is a medical device that received FDA 510(k) clearance on 2026-04-02. The listed applicant is Miracell Co., Ltd.. The 510(k) number is K250516.

When did SMART M-CELL PRP Concentration System receive FDA 510(k) clearance?

SMART M-CELL PRP Concentration System received FDA 510(k) clearance on 2026-04-02, under 510(k) number K250516.

Who is the listed applicant for SMART M-CELL PRP Concentration System?

The FDA 510(k) record lists Miracell Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMART M-CELL PRP Concentration System?

The FDA product code for SMART M-CELL PRP Concentration System is QBV.

Other records listing Miracell Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250518SMART M-CELL Bone Marrow Concentration System

Related Devices (Code: QBV)

K250518SMART M-CELL Bone Marrow Concentration SystemMiracell Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.