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Medivators Advantage Plus Endoscope Reprocessing System, Rapicide Pa High Level Disinfectant

by Medivators Reprocessing Systems

510(k) K082988

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 ongoing

This device is named in the recall

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 NumberK082988 Date13 Feb 2009ClearedStatusActive

Recalls

4 recalls · 4 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-0154-2027 FDA Class II initiated 21 Sep 2026
    • Ongoing Z-0156-2027 FDA Class II initiated 21 Sep 2026
    • Ongoing Z-0155-2027 FDA Class II initiated 21 Sep 2026

    If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in close proximity.

    • Ongoing Z-0617-2024 FDA Class II initiated 13 Nov 2023

    Identification label on affected hookups could become illegible over time due to the label's ink coming off. This may potentially prevent users from being able to effectively identify the hookup and may ultimately result in postponement of patient procedures.

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  • Withdrawn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
FEB
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Medivators Advantage Plus Endoscope Reprocessing System is an automated device designed for the cleaning and high-level disinfection of endoscopes. It monitors endoscope channels for blockages, ensures the delivery of disinfectant to all channels, and performs automated cycles to provide consistent reprocessing results.

This system is intended for use in clinical settings and is supplied with Rapicide PA High Level Disinfectant. It features automated leak testing and alcohol flushing capabilities to facilitate the maintenance of endoscopes. The device is subject to FDA 510k clearance under regulation number 876.1500.

Other devices from Medivators Reprocessing Systems

Questions

AI-generated answers, 21 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 primary function of the Medivators Advantage Plus system?

    This device is an automated system designed for the cleaning and high-level disinfection of endoscopes. It ensures consistent reprocessing results by monitoring endoscope channels for blockages and verifying that disinfectant is delivered to all channels.

  • Does the system include features for endoscope maintenance?

    Yes, the system is equipped with automated leak testing and alcohol flushing capabilities. These features are integrated into the reprocessing cycle to facilitate the routine maintenance of endoscopes during the cleaning process.

  • What disinfectant is used with this reprocessing system?

    The system is supplied for use with Rapicide PA High Level Disinfectant. This chemical agent is utilized during the automated cycles to achieve the required level of disinfection for endoscopes in clinical settings.

  • What is the regulatory status of this device?

    The Medivators Advantage Plus Endoscope Reprocessing System has received FDA 510k clearance under regulation number 876.1500. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.