Cleared Traditional

K812459 - EXMOOR AURAL GROMMET AG/TI

K812459 is an FDA 510(k) clearance for EXMOOR AURAL GROMMET AG/TI, manufactured by Exmoor Plastics , Ltd.. The device is a Class 2 Ear, Nose, Throat device with product code ETD cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K812459 · Exmoor Plastics , Ltd. · Ear, Nose, Throat device
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Sep 1981
Decision
25d
Days
Class 2
Risk

K812459 is an FDA 510(k) clearance for the EXMOOR AURAL GROMMET AG/TI. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Exmoor Plastics , Ltd. (Walker, US). The FDA issued a Cleared decision on September 25, 1981 after a review of 25 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 Exmoor Plastics , Ltd. devices

FDA 510(k) Submission Details - K812459

510(k) Number K812459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1981
Decision Date September 25, 1981
Days to Decision 25 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
64d faster than avg
Panel avg: 89d · This submission: 25d
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 68
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K812459.
TYTAN REUTER BOBBIN VENT TUBE
K822376 · Treace Medical, Inc. · Sep 1982
TYTAN GROMMET VENT TUBE, .040
K822366 · Treace Medical, Inc. · Sep 1982
REUTER BOBBIN VENTILA. TUBE-TITANIUM
K820362 · Richard'S Medical Equip., Inc. · Mar 1982
VARIOUS AURAL GROMMETS
K812460 · Exmoor Plastics , Ltd. · Sep 1981
EXMOOR AURAL GROMMET
K810701 · Exmoor Plastics , Ltd. · Apr 1981
EXMOOR AURAL GROMMET AG/T2L
K810702 · Exmoor Plastics , Ltd. · Apr 1981