510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K952691Substantially Equivalent

Welch Allyn Premium Lightweight Headlight

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

K952691 is the FDA 510(k) clearance record for WELCH ALLYN PREMIUM LIGHTWEIGHT HEADLIGHT, a class II device, cleared for Welch Allyn, Inc. on under FDA product code FJC (Detector, Blood Level). FDA records list 112 510(k) clearances for Welch Allyn, Inc., from to . As of , FDA records show no recalls naming K952691.

Clearance record

Decision date
Received
(49 days to decision)
Product code
FJC Detector, Blood Level
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Welch Allyn, Inc. 4341 State St. Rd., Skaneateles Falls NY
510(k) summary
Summary
Third party review
No

Clearances, product code FJC

Trailing 12 months

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

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