Cleared Traditional

K942745 - EXMOOR SINGLE USE MYRINGOTOMES

K942745 is an FDA 510(k) clearance for EXMOOR SINGLE USE MYRINGOTOMES, manufactured by Exmoor Plastics , Ltd.. The device is a Class 1 Ear, Nose, Throat device with product code LRC cleared through the Traditional 510(k) pathway after a 84-day FDA review.

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

FDA 510(k) Submission Details - K942745

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 89d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

LRC Device Classification - Class 1, General Controls

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 54
Devices cleared under the same product code (LRC) and FDA review panel - the closest regulatory comparables to K942745.
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SUCKER ENDS (ZOELLNER)
K942746 · Exmoor Plastics , Ltd. · Aug 1994
DISPOSABLE NASAL SCISSOR
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DISPOSABLE NASAL RONGEUR
K942064 · United States Surgical, A Division of Tyco Healthc · Jun 1994