510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901609Substantially Equivalent

Electroglottograph

Glottal Ent., Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901609 is the FDA 510(k) clearance record for ELECTROGLOTTOGRAPH, a class II device, cleared for Glottal Ent., Inc. on under FDA product code KLX (Electroglottograph). FDA records list one 510(k) clearance for Glottal Ent., Inc. As of , FDA records show no recalls naming K901609.

Clearance record

Decision date
Received
(83 days to decision)
Product code
KLX Electroglottograph
Regulation
21 CFR 874.1325
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Glottal Ent., Inc. Suite 400, Washington DC
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