Cleared Traditional

K131177 - SINUFLUSH LAVAGE SYSTEM (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K131177 · Hedgepath, LLC · Ear, Nose, Throat device
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Sep 2013
Decision
148d
Days
Class 1
Risk

K131177 is an FDA 510(k) clearance for the SINUFLUSH LAVAGE SYSTEM. Classified as Irrigator, Sinus (product code KAR), Class I - General Controls.

Submitted by Hedgepath, LLC (Tampa, US). The FDA issued a Cleared decision on September 20, 2013 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K131177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2013
Decision Date September 20, 2013
Days to Decision 148 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 89d · This submission: 148d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KAR Irrigator, Sinus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
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.