Cleared Traditional

K830584 - SOILEAU TYTAN BOBBIN VENT TUBE

K830584 is the FDA 510(k) clearance for SOILEAU TYTAN BOBBIN VENT TUBE by Treace Medical, Inc.. It is a Class 2 Ear, Nose, Throat device (product code ETD) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K830584 · Treace Medical, Inc. · Ear, Nose, Throat device
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Jun 1983
Decision
99d
Days
Class 2
Risk

K830584 is an FDA 510(k) clearance for the SOILEAU TYTAN BOBBIN 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 June 2, 1983 after a review of 99 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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

Submission Details

510(k) Number K830584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1983
Decision Date June 02, 1983
Days to Decision 99 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
10d slower than avg
Panel avg: 89d · This submission: 99d
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 K830584.
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
T-TUBE VENT TUBE
K823909 · Treace Medical, Inc. · Mar 1983
OTOLOGICAL VENTILATION TUBES-VARIOUS
K830228 · Micromedics, Inc. · Mar 1983
COLLAR BUTTON VENT TUBE
K823907 · Treace Medical, Inc. · Jan 1983