Cleared Traditional

K931946 - WELCH ALLYN EARCLEANER

K931946 is an FDA 510(k) clearance for WELCH ALLYN EARCLEANER, manufactured by Welch Allyn, Inc.. The device is a Class 1 General Hospital device with product code KYZ cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K931946 · Welch Allyn, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
98d
Days
Class 1
Risk

K931946 is an FDA 510(k) clearance for the WELCH ALLYN EARCLEANER. Classified as Syringe, Irrigating (non Dental) (product code KYZ), Class I - General Controls.

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on July 26, 1993 after a review of 98 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6960 - 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 - K931946

510(k) Number K931946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1993
Decision Date July 26, 1993
Days to Decision 98 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
31d faster than avg
Panel avg: 129d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

KYZ Device Classification - Class 1, General Controls

Product Code KYZ Syringe, Irrigating (non Dental)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6960
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 - KYZ Syringe, Irrigating (non Dental)

All 24
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