510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K200285Substantially Equivalent

VenaOne

Vena Group, LLC, San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200285 is the FDA 510(k) clearance record for VenaOne, a class II device, cleared for Vena Group, LLC on under FDA product code JOW (Sleeve, Limb, Compressible). FDA records list one 510(k) clearance for Vena Group, LLC. As of , FDA records show no recalls naming K200285.

Clearance record

Decision date
Received
(148 days to decision)
Product code
JOW Sleeve, Limb, Compressible
Regulation
21 CFR 870.5800
Device class
Class II
Review panel
Cardiovascular
Applicant
Vena Group, LLC 10 Westelm Gardens, San Antonio TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JOW

Trailing 12 months
8 clearances under product code JOW in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code JOW, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20261
March 20260
April 20261
May 20260
June 20261
July 20261
August 20261
September 20261
October 20260