Cleared Traditional

K082762 - AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE

K082762 is an FDA 510(k) clearance for AARDVARK NASAL IRRIGATION AND ASPIRATIO..., manufactured by Aardvark Medical. The device is a Class 2 General & Plastic Surgery device with product code JCX cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K082762 · Aardvark Medical · General & Plastic Surgery device
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Nov 2008
Decision
51d
Days
Class 2
Risk

K082762 is an FDA 510(k) clearance for the AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE. Classified as Apparatus, Suction, Ward Use, Portable, Ac-powered (product code JCX), Class II - Special Controls.

Submitted by Aardvark Medical (Ross, US). The FDA issued a Cleared decision on November 12, 2008 after a review of 51 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - 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.

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FDA 510(k) Submission Details - K082762

510(k) Number K082762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2008
Decision Date November 12, 2008
Days to Decision 51 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 115d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

JCX Device Classification - Class 2, Special Controls

Product Code JCX Apparatus, Suction, Ward Use, Portable, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
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 - JCX Apparatus, Suction, Ward Use, Portable, Ac-powered

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