Cleared Traditional

K091133 - APLION TOPICAL CARE SYSTEM

K091133 is an FDA 510(k) clearance for APLION TOPICAL CARE SYSTEM, manufactured by Aplion Medical,Llc. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K091133 · Aplion Medical,Llc · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
30d
Days
Class 1
Risk

K091133 is an FDA 510(k) clearance for the APLION TOPICAL CARE SYSTEM. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Aplion Medical,Llc (Salt Lake City, US). The FDA issued a Cleared decision on May 20, 2009 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4020 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K091133

510(k) Number K091133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2009
Decision Date May 20, 2009
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

NAD Device Classification - Class 1, General Controls

Product Code NAD Dressing, Wound, Occlusive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4020
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - NAD Dressing, Wound, Occlusive

All 100
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K091133.
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K091133 · APLION TOPICAL CARE SYSTEM
Download PDF FDA Summary Aplion Medical,Llc