510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821079Substantially Equivalent

Electroglottograph Naked Egg Boxed Egg

Ms. Kate Teaney, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821079 is the FDA 510(k) clearance record for ELECTROGLOTTOGRAPH NAKED EGG BOXED EGG, a class II device, cleared for Ms. Kate Teaney on under FDA product code KLX (Electroglottograph). FDA records list one 510(k) clearance for Ms. Kate Teaney. As of , FDA records show no recalls naming K821079.

Clearance record

Decision date
Received
(21 days to decision)
Product code
KLX Electroglottograph
Regulation
21 CFR 874.1325
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Ms. Kate Teaney 4221 Richmond Rd., NW, Walker MI
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