Cleared Traditional

K103595 - ACCLARENT TYMPANOSTOMY TUBE AND TYMPANO...

K103595 is the FDA 510(k) clearance for ACCLARENT TYMPANOSTOMY TUBE AND TYMPANO... by Acclarent, Inc.. It is a Class 2 Ear, Nose, Throat device (product code ETD) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K103595 · Acclarent, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
114d
Days
Class 2
Risk

K103595 is an FDA 510(k) clearance for the ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Acclarent, Inc. (Rmenlo Park, US). The FDA issued a Cleared decision on April 1, 2011 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3880 - 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 K103595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2010
Decision Date April 01, 2011
Days to Decision 114 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 89d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ETD Tube, Tympanostomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ear, Nose, Throat devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01202578 Completed Interventional Industry-sponsored

Evaluation of the Tympanostomy Tube Delivery System

A Clinical Study of the Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion for Otitis Media

53
Patients (actual)
4
Sites
Treatment
Purpose
Open label
Masking
Condition studied Otitis Media With Effusion; Acute Otitis Media
Study design Single group
Eligibility All sexes · 6 Months+
Principal investigator Kenneth Faw, MD
Sponsor Integra LifeSciences Corporation (industry)
Started 2010-09-01 → Primary completion 2010-11-01 → Completed 2010-12-01
Primary outcome
Safety of Tympanostomy Tube (TT) Delivery System
Secondary outcome
Proportion of Subjects With Procedure Success
View full study on ClinicalTrials.gov

Regulatory Peers - ETD Tube, Tympanostomy

All 45
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K103595.
Tympanostomy Tubes
K232059 · Grace Medical, Inc. · Nov 2023
Hummingbird Tympanostomy Tube System
K221254 · Preceptis Medical, Inc. · Jul 2022
Hummingbird Tympanostomy Tube System
K200952 · Preceptis Medical, Inc. · Jun 2020
TYMPANOSTOMY TUBE
K082188 · Acclarent, Inc. · Sep 2008
TM MICRO-CATHETERS
K971124 · Xomed, Inc. · May 1997
ACTIVENT ANTIMICROBIAL VENTILATION TUBES
K961873 · Xomed, Inc. · Jul 1996