510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031548Substantially Equivalent

LED Headlight

Welch Allyn Inc, Skaneateles Falls NY / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031548 is the FDA 510(k) clearance record for LED HEADLIGHT, a class II device, cleared for Welch Allyn, Inc. on under FDA product code FSR (Light, Headband, Surgical). FDA records list 112 510(k) clearances for Welch Allyn, Inc., from to . As of , FDA records show no recalls naming K031548.

Clearance record

Decision date
Received
(87 days to decision)
Product code
FSR Light, Headband, Surgical
Regulation
21 CFR 886.4335
Device class
Class II
Review panel
Ophthalmic
Applicant
Welch Allyn, Inc. 4341 State St. Rd., Skaneateles Falls NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FSR

Trailing 12 months

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

FDA records show no clearances under product code FSR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FSR, 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