Cleared Traditional

K904659 - DR. DEDO'S FAMILY EAR EXAMINATION KIT

K904659 is an FDA 510(k) clearance for DR. DEDO'S FAMILY EAR EXAMINATION KIT, manufactured by Panex Corp.. The device is a Class 1 Ear, Nose, Throat device with product code ERA cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K904659 · Panex Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1991
Decision
197d
Days
Class 1
Risk

K904659 is an FDA 510(k) clearance for the DR. DEDO'S FAMILY EAR EXAMINATION KIT. Classified as Otoscope (product code ERA), Class I - General Controls.

Submitted by Panex Corp. (North Palm Beach, US). The FDA issued a Cleared decision on April 30, 1991 after a review of 197 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 Panex Corp. devices

FDA 510(k) Submission Details - K904659

510(k) Number K904659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1990
Decision Date April 30, 1991
Days to Decision 197 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
108d slower than avg
Panel avg: 89d · This submission: 197d
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 K904659.
UNI I
K925759 · Rudolf Riester GmbH & Co. KG · Jul 1993
OTO-BRITE HANDLE
K924025 · Jedmed Instrument Co. · Nov 1992
STARKEY LABORATORIES OTOSCOPE
K922752 · Starkey Laboratories, Inc. · Sep 1992
VIDEO OTOSCOPE
K904802 · Jedmed Instrument Co. · Jan 1991
TYMPANOSCOPE
K896274 · Jedmed Instrument Co. · Jan 1990
I22 INITIALES
K862621 · Oticon Corp. · Aug 1986