Cleared Traditional

K895242 - PAPPAS TRI-FLANGE VENTILATION TUBE

K895242 is an FDA 510(k) clearance for PAPPAS TRI-FLANGE VENTILATION TUBE, manufactured by Richards Medical Co., Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETD cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K895242 · Richards Medical Co., Inc. · Ear, Nose, Throat device
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Nov 1989
Decision
88d
Days
Class 2
Risk

K895242 is an FDA 510(k) clearance for the PAPPAS TRI-FLANGE VENTILATION TUBE. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Richards Medical Co., Inc. (Memphis, US). The FDA issued a Cleared decision on November 17, 1989 after a review of 88 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 Richards Medical Co., Inc. devices

FDA 510(k) Submission Details - K895242

510(k) Number K895242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1989
Decision Date November 17, 1989
Days to Decision 88 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
1d faster than avg
Panel avg: 89d · This submission: 88d
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 K895242.
DONALDSON/SHEPARDS DR/COLLAR/SHAH VENT-MINI TUBES
K911580 · Exmoor Plastics , Ltd. · Sep 1991
SUH VENT TUBE
K910618 · Boston Medical Products, Inc. · Jun 1991
JAHN VENTILATION TUBE
K900267 · Smith & Nephew Richards, Inc. · Jun 1990
DONALDSON VENTILATION TUBES PT. # AG/S9
K883667 · Exmoor Plastics , Ltd. · Nov 1988
PUNCH MYRINGOTOMY SYSTEM
K882689 · Xomed, Inc. · Sep 1988
BIO-VENT REUTER BOBBIN TUBE
K870877 · Richards Medical Co., Inc. · Mar 1987