Cleared Traditional

K831709 - AUDIOSCOPE #23000 W/71123 CHARGING STAND

K831709 is the FDA 510(k) clearance for AUDIOSCOPE #23000 W/71123 CHARGING STAND by Welch Allyn, Inc.. It is a Class 1 Ear, Nose, Throat device (product code ERA) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K831709 · Welch Allyn, Inc. · Ear, Nose, Throat device
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Jun 1983
Decision
35d
Days
Class 1
Risk

K831709 is an FDA 510(k) clearance for the AUDIOSCOPE #23000 W/71123 CHARGING STAND. Classified as Otoscope (product code ERA), Class I - General Controls.

Submitted by Welch Allyn, Inc. (Walker, US). The FDA issued a Cleared decision on June 30, 1983 after a review of 35 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 Welch Allyn, Inc. devices

Submission Details

510(k) Number K831709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1983
Decision Date June 30, 1983
Days to Decision 35 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
54d faster than avg
Panel avg: 89d · This submission: 35d
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 20
Devices cleared under the same product code (ERA) and FDA review panel - the closest regulatory comparables to K831709.
I81 CITE
K862624 · Oticon Corp. · Aug 1986
1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B
K851745 · Artiberia · Aug 1985
1-110 OTOSCOPE SET BATTERY POWERED DIAG. SET 3PCS.
K851746 · Artiberia · May 1985
CONPHAR OTOSCOPE/OPTHALMASCOPE
K813299 · Conphar, Inc. · Jan 1982
CONPHAR OTOSCOPE
K813305 · Conphar, Inc. · Jan 1982
ILLIMINATOR, MODEL 265 NASAL
K782142 · Welch Allyn, Inc. · Jan 1979