Not Cleared Direct

DEN250006 - Amferia Wound Dressing (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN250006 · Amferia AB · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2026
Decision
340d
Days
Class 2
Risk

DEN250006 is an FDA 510(k) submission (not cleared) for the Amferia Wound Dressing. Classified as Solid Wound Dressing With Permanently Bound Antimicrobial Agent (product code SHA), Class II - Special Controls.

Submitted by Amferia AB (Molndal, SE). The FDA issued a Not Cleared (DENG) decision on February 6, 2026 after a review of 340 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4013 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 340 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Amferia AB devices

Submission Details

510(k) Number DEN250006 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 03, 2025
Decision Date February 06, 2026
Days to Decision 340 days
Submission Type Direct
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
226d slower than avg
Panel avg: 114d · This submission: 340d
Pathway characteristics

Device Classification

Product Code SHA Solid Wound Dressing With Permanently Bound Antimicrobial Agent
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4013
Definition A Solid Wound Dressing With Permanently Bound Antimicrobial Agent Consists Of A Solid Wound Dressing Containing Antimicrobial Permanently Bound To The Substrate Surface. The Solid Wound Dressing Is Used To Cover And Protect A Wound, To Absorb Exudate, And To Maintain Appropriate Moisture Balance Within The Wound And Is Intended For Use Only On External Cutaneous (skin) Wounds. The Solid Wound Dressing Is Provided Sterile In A Form Able To Hold Structural Integrity. Antimicrobials Are Used For Protectant Purposes Only To Reduce Microbial Growth Within The Solid Wound Dressing While In Use, Or To Provide An Antimicrobial Barrier To Microbial Penetration Through The Solid Wound Dressing. This Classification Does Not Include Solid Wound Dressings Containing A Medically Important Antimicrobial As Defined In The Special Controls.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.