Cleared Traditional

POREX OTOLOGY INSTRUMENTS (K873044) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K873044 · Porex Medical · Ear, Nose, Throat device
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Sep 1987
Decision
31d
Days
Class 1
Risk

K873044 is an FDA 510(k) clearance for the POREX OTOLOGY INSTRUMENTS. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by Porex Medical (Fairburn, US). The FDA issued a Cleared decision on September 4, 1987 after a review of 31 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 Porex Medical devices

Submission Details

510(k) Number K873044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1987
Decision Date September 04, 1987
Days to Decision 31 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 89d · This submission: 31d
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 64
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