Cleared Traditional

K250890 - SBC1 Cream (FDA 510(k) Clearance)

K250890 · Sioxmed, LLC · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jan 2026
Decision
293d
Days
-
Risk

K250890 is an FDA 510(k) clearance for the SBC1 Cream. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Sioxmed, LLC (Winston Salem, US). The FDA issued a Cleared decision on January 12, 2026 after a review of 293 days - an extended review cycle.

This device falls under the General & Plastic Surgery 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Sioxmed, LLC devices

Submission Details

510(k) Number K250890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2025
Decision Date January 12, 2026
Days to Decision 293 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
179d slower than avg
Panel avg: 114d · This submission: 293d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Consultant

Propharma
Jennifer Daudelin

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.

Regulatory Peers - FRO Dressing, Wound, Drug

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