Cleared Traditional

K800728 - PAPARELL TYPE 2

K800728 is the FDA 510(k) clearance for PAPARELL TYPE 2 by Xomed, Inc.. It is a Class 2 Ear, Nose, Throat device (product code ETD) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K800728 · Xomed, Inc. · Ear, Nose, Throat device

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Apr 1980

Decision

15d

Days

Class 2

Risk

K800728 is an FDA 510(k) clearance for the PAPARELL TYPE 2, BIOLITE COATED SILI-. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Xomed, Inc. (Arnold, US). The FDA issued a Cleared decision on April 16, 1980 after a review of 15 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 Xomed, Inc. devices

Submission Details

510(k) Number	K800728 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 01, 1980
Decision Date	April 16, 1980
Days to Decision	15 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

74d faster than avg

Panel avg: 89d · This submission: 15d

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 68

Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K800728.

EXMOOR AURAL GROMMET AG/T4

K810705 · Exmoor Plastics , Ltd. · Apr 1981

EXMOOR AURAL GROMMET AG/T5

K810706 · Exmoor Plastics , Ltd. · Apr 1981

GOODE T-TUBE, BIOLITE COATED SILICONE/TU

K800727 · Xomed, Inc. · Apr 1980

POPE UMBRELLA TUBE

K791680 · Xomed, Inc. · Nov 1979

VENTILATION TUBE, SHEEHY COLLAT

K790216 · Xomed, Inc. · Feb 1979

VENTILATION TUBE SILI. SHEPPARD TYPE

K781257 · Xomed, Inc. · Aug 1978

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K800728

Xomed, Inc.

Arnold, MO · US

Regulatory profile

82 submissions 81 cleared

99% clearance rate · Active in Ear, Nose, Throat

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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