Cleared Traditional

MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT (K860940) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K860940 · Micromedics, Inc. · Ear, Nose, Throat device
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May 1986
Decision
51d
Days
Class 1
Risk

K860940 is an FDA 510(k) clearance for the MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT. Classified as Unit, Examining/treatment, Ent (product code ETF), Class I - General Controls.

Submitted by Micromedics, Inc. (St. Paul, US). The FDA issued a Cleared decision on May 2, 1986 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5300 - 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 Micromedics, Inc. devices

Submission Details

510(k) Number K860940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1986
Decision Date May 02, 1986
Days to Decision 51 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
38d faster than avg
Panel avg: 89d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ETF Unit, Examining/treatment, Ent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.5300
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.