Cleared Traditional

K822017 - TYMPANOSTOMY TUBES & VARIOUS TYPES

K822017 is the FDA 510(k) clearance for TYMPANOSTOMY TUBES & VARIOUS TYPES by Kelleher Corp.. It is a Class 2 Ear, Nose, Throat device (product code ETD) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K822017 · Kelleher Corp. · Ear, Nose, Throat device
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Oct 1982
Decision
111d
Days
Class 2
Risk

K822017 is an FDA 510(k) clearance for the TYMPANOSTOMY TUBES & VARIOUS TYPES. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Kelleher Corp. (Walker, US). The FDA issued a Cleared decision on October 27, 1982 after a review of 111 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 Kelleher Corp. devices

Submission Details

510(k) Number K822017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1982
Decision Date October 27, 1982
Days to Decision 111 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
22d slower than avg
Panel avg: 89d · This submission: 111d
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 63
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K822017.
COLLAR BUTTON VENT TUBE
K823907 · Treace Medical, Inc. · Jan 1983
GROMMET VENT TUBE
K823908 · Treace Medical, Inc. · Jan 1983
COLLAR BUTTON VENT TUBE
K830085 · Treace Medical, Inc. · Jan 1983
ARMSTRONG V VENT TUBE
K822375 · Treace Medical, Inc. · Sep 1982
TYTAN REUTER BOBBIN VENT TUBE
K822376 · Treace Medical, Inc. · Sep 1982
TYTAN GROMMET VENT TUBE, .040
K822366 · Treace Medical, Inc. · Sep 1982