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FDA 510(k)

SMART M-CELL Bone Marrow Concentration System

K-Number: K250518 · 2026-04-02

ApplicantMiracell Co., Ltd.
Decision Date2026-04-02
Product CodeQBV
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SMART M-CELL Bone Marrow 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 K250518. 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 Bone Marrow Concentration System?

SMART M-CELL Bone Marrow 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 K250518.

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

SMART M-CELL Bone Marrow Concentration System received FDA 510(k) clearance on 2026-04-02, under 510(k) number K250518.

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

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

Related Clinical Trials

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.

NCT01174108Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cellsRECRUITINGNCT01384513A Two-Step Approach to Reduced Intensity Bone Marrow Transplant for Patients With Hematological MalignanciesCOMPLETEDNCT03047746Unrelated And Partially Matched Related Donor PSCT w/ T Cell Receptor (TCR) αβ Depletion for Patients With BMFACTIVE_NOT_RECRUITINGNCT03173937Unrelated Umbilical Cord Blood Transplantation for Severe Aplastic Anemia and Hypo-plastic MDS Using CordIn(TM), Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells to Expedite Engraftment and Improve Transplant OutcomeRECRUITINGNCT05258357Landmark vs. Ultrasound-Assisted Bone Marrow Biopsy Procedure StudyCOMPLETEDNCT06483100Measurable Residual Disease-Guided Post-Transplant Elranatamab MaintenanceRECRUITING

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.

K250516SMART M-CELL PRP Concentration System

Related Devices (Code: QBV)

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.

K250516SMART M-CELL PRP Concentration SystemMiracell Co., Ltd.

Official Source

View on FDA Database →

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

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