Cleared Traditional

K823910 - DONALDSON VENT TUBE

K823910 is an FDA 510(k) clearance for DONALDSON VENT TUBE, manufactured by Treace Medical, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETD cleared through the Traditional 510(k) pathway after a 329-day FDA review.

K823910 · Treace Medical, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1983
Decision
329d
Days
Class 2
Risk

K823910 is an FDA 510(k) clearance for the DONALDSON VENT TUBE. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Treace Medical, Inc. (Walker, US). The FDA issued a Cleared decision on November 22, 1983 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Treace Medical, Inc. devices

FDA 510(k) Submission Details - K823910

510(k) Number K823910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1982
Decision Date November 22, 1983
Days to Decision 329 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
239d slower than avg
Panel avg: 90d · This submission: 329d
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 89
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K823910.
GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE
K853641 · Xomed, Inc. · Jan 1986
TYMPANOSTOMY TUBES-VARIOUS
K833246 · Abco Dealers, Inc. · Jan 1985
UNIFLOW VENT TUBE
K842637 · Richards Medical Co., Inc. · Oct 1984
TSH RIA
K833910 · Syncor Intl. Corp. · Nov 1983
CONCEPT T-TUBE
K832361 · Concept, Inc. · Oct 1983
DONALDSON-TYPE VENT TUBE
K832362 · Concept, Inc. · Oct 1983