Cleared Traditional

K062540 - NASOPORE EAR, MODELS ND04, ND05 (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K062540 · Polyganics B.V., · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
49d
Days
Class 1
Risk

K062540 is an FDA 510(k) clearance for the NASOPORE EAR, MODELS ND04, ND05. Classified as Ear Wick (product code KCN), Class I - General Controls.

Submitted by Polyganics B.V., (Groningen, NL). The FDA issued a Cleared decision on October 18, 2006 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5220 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Polyganics B.V., devices

Submission Details

510(k) Number K062540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2006
Decision Date October 18, 2006
Days to Decision 49 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
40d faster than avg
Panel avg: 89d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KCN Ear Wick
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.5220
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.