510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K864641Substantially Equivalent

Ventex-Ia

Ventech Corp., Philadelphia PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864641 is the FDA 510(k) clearance record for VENTEX-IA, a class II device, cleared for Ventech Corp. on under FDA product code IKN (Electromyograph, Diagnostic). FDA records list one 510(k) clearance for Ventech Corp. As of , FDA records show no recalls naming K864641.

Clearance record

Decision date
Received
(63 days to decision)
Product code
IKN Electromyograph, Diagnostic
Regulation
21 CFR 890.1375
Device class
Class II
Review panel
Physical Medicine
Applicant
Ventech Corp. 8627 Ferndale St., Philadelphia PA
Third party review
No

Clearances, product code IKN

Trailing 12 months

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

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