510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K900404Substantially Equivalent

Varicoscreen(tm)

Promedex, Inc., Fort Woth TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900404 is the FDA 510(k) clearance record for VARICOSCREEN(TM), a class I device, cleared for Promedex, Inc. on under FDA product code KYA (System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)). FDA records list 3 510(k) clearances for Promedex, Inc., from to . As of , FDA records show no recalls naming K900404.

Clearance record

Decision date
Received
(312 days to decision)
Product code
KYA System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)
Regulation
21 CFR 884.2982
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Promedex, Inc. C/O Richard Hamer Assoc.Inc., Fort Woth TX
Third party review
No

Clearances, product code KYA

Trailing 12 months

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

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