Cleared Traditional

K250516 - SMART M-CELL PRP Concentration System (FDA 510(k) Clearance)

K250516 · Miracell Co., Ltd. · Hematology device
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Apr 2026
Decision
405d
Days
-
Risk

K250516 is an FDA 510(k) clearance for the SMART M-CELL PRP Concentration System.

Submitted by Miracell Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on April 2, 2026 after a review of 405 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Miracell Co., Ltd. devices

Submission Details

510(k) Number K250516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2025
Decision Date April 02, 2026
Days to Decision 405 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
292d slower than avg
Panel avg: 113d · This submission: 405d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QBV
Device Class -

Regulatory Consultant

Mtech Group, LLC
Dave Kim

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.