Cleared Traditional

K883667 - DONALDSON VENTILATION TUBES PT. # AG/S9

K883667 is an FDA 510(k) clearance for DONALDSON VENTILATION TUBES PT. # AG/S9, 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 80-day FDA review.

K883667 · Exmoor Plastics , Ltd. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Nov 1988
Decision
80d
Days
Class 2
Risk

K883667 is an FDA 510(k) clearance for the DONALDSON VENTILATION TUBES PT. # AG/S9. 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 November 14, 1988 after a review of 80 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 - K883667

510(k) Number K883667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1988
Decision Date November 14, 1988
Days to Decision 80 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
9d faster than avg
Panel avg: 89d · This submission: 80d
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 K883667.
SUH VENT TUBE
K910618 · Boston Medical Products, Inc. · Jun 1991
JAHN VENTILATION TUBE
K900267 · Smith & Nephew Richards, Inc. · Jun 1990
PAPPAS TRI-FLANGE VENTILATION TUBE
K895242 · Richards Medical Co., Inc. · Nov 1989
PUNCH MYRINGOTOMY SYSTEM
K882689 · Xomed, Inc. · Sep 1988
BIO-VENT REUTER BOBBIN TUBE
K870877 · Richards Medical Co., Inc. · Mar 1987
'EXMOOR' T-TUBE
K871035 · Exmoor Plastics , Ltd. · Mar 1987