Cleared Traditional

K830085 - COLLAR BUTTON VENT TUBE (FDA 510(k) Clearance)

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

K830085 · Treace Medical, Inc. · Ear, Nose, Throat device
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Jan 1983
Decision
17d
Days
Class 2
Risk

K830085 is an FDA 510(k) clearance for the COLLAR BUTTON VENT TUBE. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Treace Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1983 after a review of 17 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 Treace Medical, Inc. devices

Submission Details

510(k) Number K830085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1983
Decision Date January 28, 1983
Days to Decision 17 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 89d · This submission: 17d
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 K830085.
Tula Tympanostomy Tube Delivery Device
K252436 · Tusker Medical, Inc. · Apr 2026
Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))
K250256 · Aventamed Dac · Apr 2025
Solo+ Tympanostomy Tube Device (TTD)
K232702 · Aventamed Dac · May 2024
Biowy Tym Tube (TT)
K233658 · Biowy Corporation · Feb 2024
Tympanostomy Tubes
K232059 · Grace Medical, Inc. · Nov 2023
Hummingbird Tympanostomy Tube System
K221254 · Preceptis Medical, Inc. · Jul 2022