Cleared Traditional

TITANIUM VENTILATION TUBES (K921923) - FDA 510(k) Clearance

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

K921923 · Exmoor Plastics , Ltd. · Ear, Nose, Throat device
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Feb 1993
Decision
310d
Days
Class 2
Risk

K921923 is an FDA 510(k) clearance for the TITANIUM VENTILATION TUBES. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Exmoor Plastics , Ltd. (Taunton, GB). The FDA issued a Cleared decision on February 12, 1993 after a review of 310 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 Exmoor Plastics , Ltd. devices

Submission Details

510(k) Number K921923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1992
Decision Date February 12, 1993
Days to Decision 310 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
221d slower than avg
Panel avg: 89d · This submission: 310d
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 10
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K921923.
Hummingbird Tympanostomy Tube System
K221254 · Preceptis Medical, Inc. · Jul 2022
Hummingbird Tympanostomy Tube System
K200952 · Preceptis Medical, Inc. · Jun 2020
VENTILATION TUBES
K960477 · Smith & Nephew, Inc. · Feb 1996
TYMPANOSTOMY TUBES-VARIOUS
K833246 · Abco Dealers, Inc. · Jan 1985
TYMPANOSTOMY TUBES & VARIOUS TYPES
K822017 · Kelleher Corp. · Oct 1982