Cleared Traditional

K790216 - VENTILATION TUBE

K790216 is an FDA 510(k) clearance for VENTILATION TUBE, manufactured by Xomed, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETD cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K790216 · Xomed, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1979
Decision
13d
Days
Class 2
Risk

K790216 is an FDA 510(k) clearance for the VENTILATION TUBE, SHEEHY COLLAT. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Xomed, Inc. (Arnold, US). The FDA issued a Cleared decision on February 12, 1979 after a review of 13 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

FDA 510(k) Submission Details - K790216

510(k) Number K790216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1979
Decision Date February 12, 1979
Days to Decision 13 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
76d faster than avg
Panel avg: 89d · This submission: 13d
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 68
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K790216.
GOODE T-TUBE, BIOLITE COATED SILICONE/TU
K800727 · Xomed, Inc. · Apr 1980
PAPARELL TYPE 2, BIOLITE COATED SILI-
K800728 · Xomed, Inc. · Apr 1980
POPE UMBRELLA TUBE
K791680 · Xomed, Inc. · Nov 1979
VENTILATION TUBE SILI. SHEPPARD TYPE
K781257 · Xomed, Inc. · Aug 1978
VENTILATION TUBE. SILI. DONALDSON TYPE
K781258 · Xomed, Inc. · Aug 1978
VENTILATION TUBE TEFLON SHEPARD TYPE
K781259 · Xomed, Inc. · Aug 1978