Cleared Traditional

K922095 - LX 150 LIGHT SOURCE

K922095 is the FDA 510(k) clearance for LX 150 LIGHT SOURCE by Welch Allyn, Inc.. It is a Class 1 Ear, Nose, Throat device (product code EQH) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K922095 · Welch Allyn, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
73d
Days
Class 1
Risk

K922095 is an FDA 510(k) clearance for the LX 150 LIGHT SOURCE. Classified as Source, Carrier, Fiberoptic Light (product code EQH), Class I - General Controls.

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on July 17, 1992 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4350 - 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 K922095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1992
Decision Date July 17, 1992
Days to Decision 73 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 89d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EQH Source, Carrier, Fiberoptic Light
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4350
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 - EQH Source, Carrier, Fiberoptic Light

All 22
Devices cleared under the same product code (EQH) and FDA review panel - the closest regulatory comparables to K922095.
JED-LIGHT FIBEROPTIC LIGHT SOURCE
K954184 · Jedmed Instrument Co. · Nov 1995
KAPS 90 DEGREE FIBEROPTIC ADAPTOR
K912885 · Jedmed Instrument Co. · Aug 1991
FIBEROPTIC LIGHT SOURCE, FOI-1A
K896384 · Jedmed Instrument Co. · Jan 1990
ZIMMER VIDEO PRODUCTS AUTOMATIC LIGHT SOURCE
K854751 · Aspen Laboratories, Inc. · Feb 1986
VENT TUBE FORCEPS
K831589 · Treace Medical, Inc. · Jun 1983
T-TUBE INSERTER
K831590 · Treace Medical, Inc. · Jun 1983