Cleared Abbreviated

CHIN-UP STRIP (K040491) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K040491 · Dale Miller, Inc. - the Chin-Up Company · Ear, Nose, Throat device
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Sep 2004
Decision
197d
Days
Class 1
Risk

K040491 is an FDA 510(k) clearance for the CHIN-UP STRIP. Classified as Dilator, Nasal (product code LWF), Class I - General Controls.

Submitted by Dale Miller, Inc. - the Chin-Up Company (Dracula, US). The FDA issued a Cleared decision on September 10, 2004 after a review of 197 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3900 - the FDA ear, nose and throat device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Dale Miller, Inc. - the Chin-Up Company devices

Submission Details

510(k) Number K040491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2004
Decision Date September 10, 2004
Days to Decision 197 days
Submission Type Abbreviated
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 89d · This submission: 197d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code LWF Dilator, Nasal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3900
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.