Cleared Traditional

AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM (K131096) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K131096 · Arobella Medical, LLC · General & Plastic Surgery device
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May 2014
Decision
393d
Days
Class 2
Risk

K131096 is an FDA 510(k) clearance for the AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM. Classified as Wound Cleaner, Ultrasound (product code NRB), Class II - Special Controls.

Submitted by Arobella Medical, LLC (Minnetonka, US). The FDA issued a Cleared decision on May 16, 2014 after a review of 393 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4410 - 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: Standard predicate-based submission. Elevated predicate reliance profile. 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.

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Submission Details

510(k) Number K131096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2013
Decision Date May 16, 2014
Days to Decision 393 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
278d slower than avg
Panel avg: 115d · This submission: 393d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NRB Wound Cleaner, Ultrasound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4410
Definition The Ultrasound Wound Cleaner/mild Debridement System Is A Device That Delivers A Cleaning Fluid To The Wound That Is Pulsed Using Low Power Ultrasound Radiation. The Device Is Intended To Clean And Mildly Debride Wounds. The Ultrasound Generator Must Deliver 1.0 Mw/cm2 Or Less Energy To The Wound
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.