Cleared Traditional

K140542 - NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K140542 · Rhinosystems, Inc. · Ear, Nose, Throat device
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Jun 2014
Decision
115d
Days
Class 1
Risk

K140542 is an FDA 510(k) clearance for the NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER. Classified as Irrigator, Powered Nasal (product code KMA), Class I - General Controls.

Submitted by Rhinosystems, Inc. (Brooklyn Heights, US). The FDA issued a Cleared decision on June 27, 2014 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5550 - 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.

View all Rhinosystems, Inc. devices

Submission Details

510(k) Number K140542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2014
Decision Date June 27, 2014
Days to Decision 115 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
26d slower than avg
Panel avg: 89d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMA Irrigator, Powered Nasal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.5550
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.