Cleared Traditional

K974008 - PFLEIDERER'S INTRATYMPANIC CATHETER (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K974008 · Exmoor Plastics , Ltd. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
May 1998
Decision
208d
Days
Class 2
Risk

K974008 is an FDA 510(k) clearance for the PFLEIDERER'S INTRATYMPANIC CATHETER. 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 May 13, 1998 after a review of 208 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

Submission Details

510(k) Number K974008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1997
Decision Date May 13, 1998
Days to Decision 208 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 89d · This submission: 208d
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 115
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K974008.
Tula Tympanostomy Tube Delivery Device
K252436 · Tusker Medical, Inc. · Apr 2026
Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))
K250256 · Aventamed Dac · Apr 2025
Solo+ Tympanostomy Tube Device (TTD)
K232702 · Aventamed Dac · May 2024
Biowy Tym Tube (TT)
K233658 · Biowy Corporation · Feb 2024
Tympanostomy Tubes
K232059 · Grace Medical, Inc. · Nov 2023
Hummingbird Tympanostomy Tube System
K221254 · Preceptis Medical, Inc. · Jul 2022