FDA 510(k) clearance · back to tracker

SMART M-CELL Bone Marrow Concentration System

Miracell Co., Ltd. cleared K250518 on 2026-04-02, decision: substantially equivalent

K-number

K250518

Sponsor

Miracell Co., Ltd.

Device

SMART M-CELL Bone Marrow Concentration System

Class

Class I

Decision

Substantially Equivalent

Decision date

2026-04-02

Product code

QBV

Advisory committee

Clinical Chemistry

Medical specialty

Clinical Chemistry

Regulation number

862.2050

Official FDA record

Open K250518on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.