Cleared Traditional

Spectricept Skin and Wound Cleanser (K243875) - FDA 510(k) Clearance

K243875 · Spectrum Antimicrobials, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
125d
Days
-
Risk

K243875 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. (Petaluma, US). The FDA issued a Cleared decision on April 21, 2025 after a review of 125 days - within the typical 510(k) review window.

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 Spectrum Antimicrobials, Inc. devices

Submission Details

510(k) Number K243875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2024
Decision Date April 21, 2025
Days to Decision 125 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
10d slower than avg
Panel avg: 115d · This submission: 125d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Consultant

Dunn Regulatory Associates, LLC
Andrew Bosco

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

All 168
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K243875.
Granudacyn® Wound Irrigation Solution
K243415 · P.G.F. Industry Solutions GmbH · Jul 2025
Bonvadis®
K251093 · Oneness Biotech Co., Ltd. · Jun 2025
Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel
K243457 · Seriously Clean, Ltd. · May 2025
SiOxC Cream
K242406 · Sioxmed, LLC · Mar 2025
Sterile Water USP and Sterile 0.9% Normal Saline USP
K243001 · Laboratorios Biogalenic S.A. DE C.V. · Mar 2025
LUOFUCON® Silver Collagen Dressing
K240809 · Huizhou Foryou Medical Devices Co., Ltd. · Dec 2024