Cleared Traditional

IMEDGE VIDEO OSTOSCOPE (ANALOG) (K951255) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K951255 · Introspect, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
41d
Days
Class 1
Risk

K951255 is an FDA 510(k) clearance for the IMEDGE VIDEO OSTOSCOPE (ANALOG). Classified as Otoscope (product code ERA), Class I - General Controls.

Submitted by Introspect, Inc. (Excelsior, US). The FDA issued a Cleared decision on April 13, 1995 after a review of 41 days - a notably fast clearance 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: 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 Introspect, Inc. devices

Submission Details

510(k) Number K951255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1995
Decision Date April 13, 1995
Days to Decision 41 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
48d faster than avg
Panel avg: 89d · This submission: 41d
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.