Cleared Traditional

K200285 - VenaOne

K200285 is an FDA 510(k) clearance for VenaOne, manufactured by Vena Group, LLC. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K200285 · Vena Group, LLC · Cardiovascular device
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Jul 2020
Decision
148d
Days
Class 2
Risk

K200285 is an FDA 510(k) clearance for the VenaOne. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Vena Group, LLC (San Antonio, US). The FDA issued a Cleared decision on July 2, 2020 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Vena Group, LLC devices

FDA 510(k) Submission Details - K200285

510(k) Number K200285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2020
Decision Date July 02, 2020
Days to Decision 148 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 125d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOW Device Classification - Class 2, Special Controls

Product Code JOW Sleeve, Limb, Compressible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Jkh USA, LLC
Bill Quanqin Dai

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JOW Sleeve, Limb, Compressible

All 115
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K200285.
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Zeroveno
K192337 · Dimedi Co., Ltd. · Jun 2020
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Aria System
K200564 · Inova Labs · Apr 2020