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Aria System

by Inova Labs, Inc. 510(k)

Active United States

510(k) K200564

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK200564 Date3 Apr 2020ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JOW
FDA applicant
Inova Labs
Device Class
Class II
Regulation
21 CFR Part 870.5800
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Aria System is a compressible limb sleeve classified as a Class II medical device under the Cardiovascular medical specialty. It is intended for use in medical applications related to limb compression.

The device is supplied as a single-use item and is not reusable. It is not specified whether the device is sterile or non-sterile. The Aria System is not MRI safe. Storage requirements are not specified in the provided data. The device has received FDA 510(k) clearance under K200564.

Other devices from Inova Labs, Inc.