Cleared Traditional

K896274 - TYMPANOSCOPE

K896274 is the FDA 510(k) clearance for TYMPANOSCOPE 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 88-day FDA review.

K896274 · Jedmed Instrument Co. · Ear, Nose, Throat device
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Jan 1990
Decision
88d
Days
Class 1
Risk

K896274 is an FDA 510(k) clearance for the TYMPANOSCOPE. 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 January 26, 1990 after a review of 88 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 K896274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1989
Decision Date January 26, 1990
Days to Decision 88 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 89d · This submission: 88d
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 K896274.
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
I22 INITIALES
K862621 · Oticon Corp. · Aug 1986
I81 CITE
K862624 · Oticon Corp. · Aug 1986
1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B
K851745 · Artiberia · Aug 1985