510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K952289Substantially Equivalent

Welch Allyn Fiber Optic Headlignt

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

K952289 is the FDA 510(k) clearance record for WELCH ALLYN FIBER OPTIC HEADLIGNT, a class II device, cleared for Welch Allyn, Inc. on under FDA product code HPQ (Headlamp, Operating, Ac-Powered). FDA records list 112 510(k) clearances for Welch Allyn, Inc., from to . As of , FDA records show no recalls naming K952289.

Clearance record

Decision date
Received
(59 days to decision)
Product code
HPQ Headlamp, Operating, Ac-Powered
Regulation
21 CFR 886.4335
Device class
Class II
Review panel
Ophthalmic
Applicant
Welch Allyn, Inc. 4341 S. State St. Rd., Skaneateles Falls NY
510(k) summary
Summary
Third party review
No

Clearances, product code HPQ

Trailing 12 months

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

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