Cleared Traditional

K882689 - PUNCH MYRINGOTOMY SYSTEM

K882689 is the FDA 510(k) clearance for PUNCH MYRINGOTOMY SYSTEM by Xomed, Inc.. It is a Class 2 Ear, Nose, Throat device (product code ETD) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K882689 · Xomed, Inc. · Ear, Nose, Throat device
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Sep 1988
Decision
75d
Days
Class 2
Risk

K882689 is an FDA 510(k) clearance for the PUNCH MYRINGOTOMY SYSTEM. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on September 13, 1988 after a review of 75 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.

View all Xomed, Inc. devices

Submission Details

510(k) Number K882689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1988
Decision Date September 13, 1988
Days to Decision 75 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 89d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. 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 68
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K882689.
JAHN VENTILATION TUBE
K900267 · Smith & Nephew Richards, Inc. · Jun 1990
PAPPAS TRI-FLANGE VENTILATION TUBE
K895242 · Richards Medical Co., Inc. · Nov 1989
DONALDSON VENTILATION TUBES PT. # AG/S9
K883667 · Exmoor Plastics , Ltd. · Nov 1988
BIO-VENT REUTER BOBBIN TUBE
K870877 · Richards Medical Co., Inc. · Mar 1987
'EXMOOR' T-TUBE
K871035 · Exmoor Plastics , Ltd. · Mar 1987
VENTILATION TUBES WITH HYDROGEL COATING
K870129 · Richards Medical Co., Inc. · Feb 1987