Cleared Traditional

K213514 - Spectricept Skin and Wound Cleanser (FDA 510(k) Clearance)

K213514 · Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2023
Decision
437d
Days
-
Risk

K213514 is an FDA 510(k) clearance for the Spectricept Skin and Wound Cleanser. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. (Petaluma, US). The FDA issued a Cleared decision on January 13, 2023 after a review of 437 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 General & Plastic Surgery submissions.

View all Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. devices

Submission Details

510(k) Number K213514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2021
Decision Date January 13, 2023
Days to Decision 437 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
323d slower than avg
Panel avg: 114d · This submission: 437d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Consultant

Dunn Regulatory Associates, LLC
Dana Dunn

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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