Cleared Traditional

K201115 - Next Generation Balloon Dilation System (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K201115 · Acclarent, Inc. · Ear, Nose, Throat device
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Aug 2020
Decision
122d
Days
Class 1
Risk

K201115 is an FDA 510(k) clearance for the Next Generation Balloon Dilation System. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by Acclarent, Inc. (Irvine, US). The FDA issued a Cleared decision on August 27, 2020 after a review of 122 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.

View all Acclarent, Inc. devices

Submission Details

510(k) Number K201115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2020
Decision Date August 27, 2020
Days to Decision 122 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
33d slower than avg
Panel avg: 89d · This submission: 122d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRC Instrument, Ent Manual Surgical
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.