Cleared Traditional

K140782 - ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR

K140782 is an FDA 510(k) clearance for ULTRAMIST SYSTEM, manufactured by Celleration, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NRB cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K140782 · Celleration, Inc. · General & Plastic Surgery device
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Aug 2014
Decision
135d
Days
Class 2
Risk

K140782 is an FDA 510(k) clearance for the ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST AP.... Classified as Wound Cleaner, Ultrasound (product code NRB), Class II - Special Controls.

Submitted by Celleration, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on August 13, 2014 after a review of 135 days - within the typical 510(k) review window.

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. 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.

FDA 510(k) Submission Details - K140782

510(k) Number K140782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2014
Decision Date August 13, 2014
Days to Decision 135 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 115d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NRB Device Classification - Class 2, Special Controls

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.

Regulatory Peers - NRB Wound Cleaner, Ultrasound

All 8
Devices cleared under the same product code (NRB) and FDA review panel - the closest regulatory comparables to K140782.
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MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES
K112782 · Misonix, Inc. · Dec 2011
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K091038 · Arobella Medical, LLC · Jun 2009
K140782 · ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR
Download PDF Celleration, Inc.