Cleared Traditional

K974007 - SHAH PERMAVENT

K974007 is an FDA 510(k) clearance for SHAH PERMAVENT, 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 52-day FDA review.

K974007 · 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
Dec 1997
Decision
52d
Days
Class 2
Risk

K974007 is an FDA 510(k) clearance for the SHAH PERMAVENT. 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 December 12, 1997 after a review of 52 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 Exmoor Plastics , Ltd. devices

FDA 510(k) Submission Details - K974007

510(k) Number K974007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1997
Decision Date December 12, 1997
Days to Decision 52 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
38d faster than avg
Panel avg: 90d · This submission: 52d
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 K974007.
TYMPANOSTOMY TUBE
K981575 · Grace Medical, Inc. · Jul 1998
PFLEIDERER'S INTRATYMPANIC CATHETER
K974008 · Exmoor Plastics , Ltd. · May 1998
ROUND WINDOW E-CATH
K973740 · Neuro-Biometrix, Inc. · Mar 1998
TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATION TUBE, MINIMAL T)
K973226 · Heinz Kurz GmbH Medizintechnik · Nov 1997
MYRINGOTOMY TUBE
K972126 · Mednet Locator, Inc. · Jul 1997
MYRINGOTOMY TUBE
K971943 · Mednet Locator, Inc. · Jul 1997