Cleared Traditional

K974008 - PFLEIDERER'S INTRATYMPANIC CATHETER

K974008 is an FDA 510(k) clearance for PFLEIDERER'S INTRATYMPANIC CATHETER, 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 208-day FDA review.

K974008 · Exmoor Plastics , Ltd. · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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

FDA 510(k) Submission Details - K974008

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 90d · This submission: 208d
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 93
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K974008.
FLUOROPLASTIC VENTILATION TUBES
K992222 · Gyrus Ent LLC · Aug 1999
EXMOOR MYRINGOTOMY KIT
K980828 · Exmoor Plastics , Ltd. · Oct 1998
TYMPANOSTOMY TUBE
K981575 · Grace Medical, Inc. · Jul 1998
ROUND WINDOW E-CATH
K973740 · Neuro-Biometrix, Inc. · Mar 1998
SHAH PERMAVENT
K974007 · Exmoor Plastics , Ltd. · Dec 1997
TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATION TUBE, MINIMAL T)
K973226 · Heinz Kurz GmbH Medizintechnik · Nov 1997