Cleared Traditional

K200564 - Aria System

K200564 is an FDA 510(k) clearance for Aria System, manufactured by Inova Labs. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K200564 · Inova Labs · Cardiovascular device
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Apr 2020
Decision
30d
Days
Class 2
Risk

K200564 is an FDA 510(k) clearance for the Aria System. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Inova Labs (San Diego, US). The FDA issued a Cleared decision on April 3, 2020 after a review of 30 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Inova Labs devices

FDA 510(k) Submission Details - K200564

510(k) Number K200564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2020
Decision Date April 03, 2020
Days to Decision 30 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Accelerated Device Approval Services
Rafael Aguila

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 K200564.
VenaOne
K200285 · Vena Group, LLC · Jul 2020
Zeroveno
K192337 · Dimedi Co., Ltd. · Jun 2020
Koya Ripple
K193288 · Koya, Inc. · Jun 2020
Compression Therapy Device
K191856 · Guangzhou Longest Science & Technology Co., Ltd. · Mar 2020
Ezvena IPC, Ezvena SQS
K191937 · Eezcare Medical Corp · Jan 2020
VenaPro Vascular Therapy System
K193020 · Innovamed Health, LLC · Dec 2019