Cleared Traditional

K973226 - TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATION TUBE, MINIMAL T) (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K973226 · Heinz Kurz GmbH Medizintechnik · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
69d
Days
Class 2
Risk

K973226 is an FDA 510(k) clearance for the TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DI.... Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Heinz Kurz GmbH Medizintechnik (Dusslingen, DE). The FDA issued a Cleared decision on November 4, 1997 after a review of 69 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 Heinz Kurz GmbH Medizintechnik devices

Submission Details

510(k) Number K973226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1997
Decision Date November 04, 1997
Days to Decision 69 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
20d faster than avg
Panel avg: 89d · This submission: 69d
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 115
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K973226.
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