Cleared Traditional

K924025 - OTO-BRITE HANDLE

K924025 is the FDA 510(k) clearance for OTO-BRITE HANDLE by Jedmed Instrument Co.. It is a Class 1 Ear, Nose, Throat device (product code ERA) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K924025 · Jedmed Instrument Co. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Nov 1992
Decision
87d
Days
Class 1
Risk

K924025 is an FDA 510(k) clearance for the OTO-BRITE HANDLE. Classified as Otoscope (product code ERA), Class I - General Controls.

Submitted by Jedmed Instrument Co. (St.Louis, US). The FDA issued a Cleared decision on November 6, 1992 after a review of 87 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 Jedmed Instrument Co. devices

Submission Details

510(k) Number K924025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1992
Decision Date November 06, 1992
Days to Decision 87 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 89d · This submission: 87d
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.

Regulatory Peers - ERA Otoscope

All 29
Devices cleared under the same product code (ERA) and FDA review panel - the closest regulatory comparables to K924025.
RI-SCOPE (S)
K932506 · Rudolf Riester GmbH & Co. KG · Oct 1993
OTOSCOPE
K925758 · Rudolf Riester GmbH & Co. KG · Aug 1993
UNI I
K925759 · Rudolf Riester GmbH & Co. KG · Jul 1993
STARKEY LABORATORIES OTOSCOPE
K922752 · Starkey Laboratories, Inc. · Sep 1992
VIDEO OTOSCOPE
K904802 · Jedmed Instrument Co. · Jan 1991
TYMPANOSCOPE
K896274 · Jedmed Instrument Co. · Jan 1990