Cleared Traditional

K911580 - DONALDSON/SHEPARDS DR/COLLAR/SHAH VENT-...

K911580 is an FDA 510(k) clearance for DONALDSON/SHEPARDS DR/COLLAR/SHAH VENT-..., 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 174-day FDA review.

K911580 · Exmoor Plastics , Ltd. · Ear, Nose, Throat device
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Sep 1991
Decision
174d
Days
Class 2
Risk

K911580 is an FDA 510(k) clearance for the DONALDSON/SHEPARDS DR/COLLAR/SHAH VENT-MINI 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 September 24, 1991 after a review of 174 days - an extended review 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: 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 Exmoor Plastics , Ltd. devices

FDA 510(k) Submission Details - K911580

510(k) Number K911580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1991
Decision Date September 24, 1991
Days to Decision 174 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
85d slower than avg
Panel avg: 89d · This submission: 174d
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 K911580.
SILICONE TYMPANOSTOMY TUBES
K932166 · Smith & Nephew Richards, Inc. · Jul 1993
BEL-AIR VENTILATION TUBE
K926462 · Exmoor Plastics , Ltd. · May 1993
TITANIUM VENTILATION TUBES
K921923 · Exmoor Plastics , Ltd. · Feb 1993
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