510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K922095Substantially Equivalent

Lx 150 Light Source

Welch Allyn Inc, Skaneateles Falls NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922095 is the FDA 510(k) clearance record for LX 150 LIGHT SOURCE, a class I device, cleared for Welch Allyn, Inc. on under FDA product code EQH (Source, Carrier, Fiberoptic Light). FDA records list 112 510(k) clearances for Welch Allyn, Inc., from to . As of , FDA records show no recalls naming K922095.

Clearance record

Decision date
Received
(73 days to decision)
Product code
EQH Source, Carrier, Fiberoptic Light
Regulation
21 CFR 874.4350
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Welch Allyn, Inc. 4341 State St. Rd., Skaneateles Falls NY
510(k) summary
Summary
Third party review
No

Clearances, product code EQH

Trailing 12 months

FDA records hold no clearances under product code EQH in the trailing twelve months.

FDA records show no clearances under product code EQH in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EQH, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260