Cleared Traditional

K851746 - 1-110 OTOSCOPE SET BATTERY POWERED DIAG...

K851746 is an FDA 510(k) clearance for 1-110 OTOSCOPE SET BATTERY POWERED DIAG..., manufactured by Artiberia. The device is a Class 1 Ear, Nose, Throat device with product code ERA cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K851746 · Artiberia · Ear, Nose, Throat device
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May 1985
Decision
34d
Days
Class 1
Risk

K851746 is an FDA 510(k) clearance for the 1-110 OTOSCOPE SET BATTERY POWERED DIAG. SET 3PCS.. Classified as Otoscope (product code ERA), Class I - General Controls.

Submitted by Artiberia (San Antonio, US). The FDA issued a Cleared decision on May 29, 1985 after a review of 34 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 Artiberia devices

FDA 510(k) Submission Details - K851746

510(k) Number K851746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1985
Decision Date May 29, 1985
Days to Decision 34 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
55d faster than avg
Panel avg: 89d · This submission: 34d
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 K851746.
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
AUDIOSCOPE #23000 W/71123 CHARGING STAND
K831709 · Welch Allyn, Inc. · Jun 1983
CONPHAR OTOSCOPE/OPTHALMASCOPE
K813299 · Conphar, Inc. · Jan 1982
CONPHAR OTOSCOPE
K813305 · Conphar, Inc. · Jan 1982