Cleared Traditional

K950983 - IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO...

K950983 is an FDA 510(k) clearance for IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO..., manufactured by Introspect, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ERA cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K950983 · Introspect, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
40d
Days
Class 1
Risk

K950983 is an FDA 510(k) clearance for the IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE. Classified as Otoscope (product code ERA), Class I - General Controls.

Submitted by Introspect, Inc. (Excelsior, US). The FDA issued a Cleared decision on April 12, 1995 after a review of 40 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

FDA 510(k) Submission Details - K950983

510(k) Number K950983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1995
Decision Date April 12, 1995
Days to Decision 40 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
49d faster than avg
Panel avg: 89d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

ERA Device Classification - Class 1, General Controls

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.

Regulatory Peers - ERA Otoscope

All 30
Devices cleared under the same product code (ERA) and FDA review panel - the closest regulatory comparables to K950983.
WELCH ALLYN BI-OTOSCOPE
K955043 · Welch Allyn, Inc. · Nov 1995
WELCH ALLY OTOSCOPE
K952578 · Welch Allyn, Inc. · Jul 1995
PERFECT, ENT SET, PRAKTIKANT, DE LUXE
K950913 · Rudolf Riester GmbH & Co. KG · May 1995
WELCH ALLYN OTOSCOPE
K950787 · Welch Allyn, Inc. · Apr 1995
H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CG
K946043 · Rudolf Riester GmbH & Co. KG · Mar 1995
OTOVIEW TELESCOPIC OTOSCOPES
K943721 · Smith & Nephew, Inc. · Nov 1994