Cleared Traditional

K082188 - TYMPANOSTOMY TUBE

K082188 is an FDA 510(k) clearance for TYMPANOSTOMY TUBE, manufactured by Acclarent, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETD cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K082188 · Acclarent, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
46d
Days
Class 2
Risk

K082188 is an FDA 510(k) clearance for the TYMPANOSTOMY TUBE. 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 September 19, 2008 after a review of 46 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K082188

510(k) Number K082188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2008
Decision Date September 19, 2008
Days to Decision 46 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
44d faster than avg
Panel avg: 90d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETD Device Classification - Class 2, Special Controls

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ETD Tube, Tympanostomy

All 113
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K082188.
HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS)
K142282 · Preceptis Medical · Apr 2015
PRECEPTIS TYMPANOSTOMY TUBE INSERTER
K133921 · Preceptis Medical · Aug 2014
ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM
K103595 · Acclarent, Inc. · Apr 2011
TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE
K071150 · Heinz Kurz GmbH Medizintechnik · Dec 2007
OTOMEDICS SOFT TYMPANOSTOMY TUBE
K071178 · Otomedics Advanced Medical Technologies, Ltd. · Jun 2007
GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES
K062672 · Grace Medical, Inc. · Oct 2006
K082188 · TYMPANOSTOMY TUBE
Download PDF FDA Summary Acclarent, Inc.