Cleared Traditional

K920103 - EPISCOPE, MODEL 47300

K920103 is an FDA 510(k) clearance for EPISCOPE, manufactured by Welch Allyn, Inc.. The device is a Class 1 General Hospital device with product code KZF cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K920103 · Welch Allyn, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1992
Decision
110d
Days
Class 1
Risk

K920103 is an FDA 510(k) clearance for the EPISCOPE, MODEL 47300. Classified as Device, Medical Examination, Ac Powered (product code KZF), Class I - General Controls.

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on April 28, 1992 after a review of 110 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6320 - the FDA general hospital 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Welch Allyn, Inc. devices

FDA 510(k) Submission Details - K920103

510(k) Number K920103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1992
Decision Date April 28, 1992
Days to Decision 110 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 129d · This submission: 110d
Pathway characteristics
Predicate-based equivalence.

KZF Device Classification - Class 1, General Controls

Product Code KZF Device, Medical Examination, Ac Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6320
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 - KZF Device, Medical Examination, Ac Powered

All 14
Devices cleared under the same product code (KZF) and FDA review panel - the closest regulatory comparables to K920103.
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