Cleared Traditional

K932259 - CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K932259 · Clarus Medical Systems, Inc. · Ear, Nose, Throat device
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Dec 1993
Decision
239d
Days
Class 1
Risk

K932259 is an FDA 510(k) clearance for the CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE. Classified as Otoscope (product code ERA), Class I - General Controls.

Submitted by Clarus Medical Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 15, 1993 after a review of 239 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4770 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Clarus Medical Systems, Inc. devices

Submission Details

510(k) Number K932259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1993
Decision Date December 15, 1993
Days to Decision 239 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 89d · This submission: 239d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ERA Otoscope
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4770
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.