510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K990240Substantially Equivalent

Electroglottograph

Kay Elemetrics Corp., Lincoln Park NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990240 is the FDA 510(k) clearance record for ELECTROGLOTTOGRAPH, a class II device, cleared for Kay Elemetrics Corp. on under FDA product code KLX (Electroglottograph). FDA records list 5 510(k) clearances for Kay Elemetrics Corp., from to . As of , FDA records show no recalls naming K990240.

Clearance record

Decision date
Received
(45 days to decision)
Product code
KLX Electroglottograph
Regulation
21 CFR 874.1325
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Kay Elemetrics Corp. 2 Bridgewater Ln., Lincoln Park NJ
510(k) summary
Statement
Third party review
No

Clearances, product code KLX

Trailing 12 months

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

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