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Reprocessed Used Disposable Sequential Compression Sleeves/Wraps

by Adven Medical

510(k) K012675

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK012675 Date12 Feb 2002ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

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

Overview

AI-generated summary, 22 Sep 2026

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

Reprocessed used disposable sequential compression sleeves/wraps are devices intended to increase venous blood flow in non-ambulatory patients to prevent deep vein thrombosis and pulmonary embolism. They function by applying sequential compression to limbs.

These devices are reprocessed by Adven Medical, Inc. per protocol 40009 to render used single-use devices patient-ready, including cleaning and sterilization. They are supplied as reprocessed single-use devices and are authorized under FDA 510(k) clearance K012675.

Other devices from Adven Medical

Questions

AI-generated answers, 22 Sep 2026

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

  • What is the intended use of reprocessed used disposable sequential compression sleeves/wraps?

    These devices are intended to increase venous blood flow in non-ambulatory patients to prevent deep vein thrombosis and pulmonary embolism by applying sequential compression to limbs.

  • How are these devices supplied and prepared for use?

    They are supplied as reprocessed single-use devices after being cleaned and sterilized by Adven Medical per protocol 40009 to render used single-use devices patient-ready.

  • Are reprocessed used disposable sequential compression sleeves/wraps intended for single use or reuse?

    They are supplied as reprocessed single-use devices, meaning they are intended for one patient use after reprocessing, despite originating from previously used disposable devices.