Cleared Traditional

EXMOOR SINGLE USE MYRINGOTOMES (K942745) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K942745 · Exmoor Plastics , Ltd. · Ear, Nose, Throat device
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Sep 1994
Decision
84d
Days
Class 1
Risk

K942745 is an FDA 510(k) clearance for the EXMOOR SINGLE USE MYRINGOTOMES. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by Exmoor Plastics , Ltd. (Taunton, GB). The FDA issued a Cleared decision on September 2, 1994 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - 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

Submission Details

510(k) Number K942745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1994
Decision Date September 02, 1994
Days to Decision 84 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 89d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRC Instrument, Ent Manual Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LRC Instrument, Ent Manual Surgical

All 12
Devices cleared under the same product code (LRC) and FDA review panel - the closest regulatory comparables to K942745.
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DISPOSABLE ENT PUNCH
K942065 · United States Surgical, A Division of Tyco Healthc · Jun 1994