Cleared Traditional

K981045 - EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS

K981045 is an FDA 510(k) clearance for EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS, manufactured by Exmoor Plastics , Ltd.. The device is a Class 2 Ear, Nose, Throat device with product code ETB cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K981045 · Exmoor Plastics , Ltd. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
61d
Days
Class 2
Risk

K981045 is an FDA 510(k) clearance for the EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS. Classified as Prosthesis, Partial Ossicular Replacement (product code ETB), Class II - Special Controls.

Submitted by Exmoor Plastics , Ltd. (Taunton, GB). The FDA issued a Cleared decision on May 20, 1998 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3450 - 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 - K981045

510(k) Number K981045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1998
Decision Date May 20, 1998
Days to Decision 61 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
28d faster than avg
Panel avg: 89d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETB Device Classification - Class 2, Special Controls

Product Code ETB Prosthesis, Partial Ossicular Replacement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3450
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 - ETB Prosthesis, Partial Ossicular Replacement

All 37
Devices cleared under the same product code (ETB) and FDA review panel - the closest regulatory comparables to K981045.
WEHRS INCUS-STAPES
K000858 · Gyrus Ent LLC · Apr 2000
CAP PORP, CAP TORP
K000256 · Gyrus Ent LLC · Feb 2000
MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
K993234 · Micromedics, Inc. · Nov 1999
MILLS INCUS HA SLEEVE
K974365 · Exmoor Plastics , Ltd. · Jan 1998
ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS
K964909 · Xomed, Inc. · Mar 1997
RICHARDS TOTAL/PARTIAL PROSTHESIS
K962564 · Gyrus Ent LLC · Jan 1997