SMART M-CELL Bone Marrow Concentration System— 510(k) K250518

Name: FDA 510(k) clearance K250518
Creator: U.S. Food and Drug Administration
Published: 2026-04-02

Substantially Equivalent

Miracell Co., Ltd.

FDA 510(k) clearance K250518 for SMART M-CELL Bone Marrow Concentration System, Substantially Equivalent on 2026-04-02. Applicant: Miracell Co., Ltd.. Device class: 1.

Clearance details

Applicant: Miracell Co., Ltd.
Product code: Code QBV
Device class: Class 1
Regulation: 21 CFR 862.2050
Advisory panel: Clinical Chemistry
Date received: 2025-02-21
Decision date: 2026-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code QBV

view all

K250516 — SMART M-CELL PRP Concentration System2026-04-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.