Cleared Traditional

K800365 - EARSCOPE

K800365 is an FDA 510(k) clearance for EARSCOPE, manufactured by Nash & Assoc.. The device is a Class 1 Ear, Nose, Throat device with product code ERA cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K800365 · Nash & Assoc. · Ear, Nose, Throat device
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Mar 1980
Decision
19d
Days
Class 1
Risk

K800365 is an FDA 510(k) clearance for the EARSCOPE. Classified as Otoscope (product code ERA), Class I - General Controls.

Submitted by Nash & Assoc. (Mchenry, US). The FDA issued a Cleared decision on March 10, 1980 after a review of 19 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 Nash & Assoc. devices

FDA 510(k) Submission Details - K800365

510(k) Number K800365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1980
Decision Date March 10, 1980
Days to Decision 19 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
70d faster than avg
Panel avg: 89d · This submission: 19d
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 K800365.
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
ILLIMINATOR, MODEL 265 NASAL
K782142 · Welch Allyn, Inc. · Jan 1979
OTOSCOPE, DIAG. MODELS 20100 & 20200
K781029 · Welch Allyn, Inc. · Jun 1978
OTOSCOPE/ILLUMINATOR, MODEL #21100
K770769 · Welch Allyn, Inc. · Apr 1977