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Quantumn Centrifugal Drive - High Pressure, Quantumn Centrifugal Drive - Medium Pressure

by Spectrum Medical Ltd 510(k)

Active United States

510(k) K192838

Overview

The Quantumn Centrifugal Drive is a control device for pump speed used in cardiopulmonary bypass procedures. It is available in high pressure and medium pressure configurations to meet different clinical needs. The medium-pressure version processes data at a slower rate, suited for routine monitoring and checkups, while still providing efficient and reliable data.

The device is manufactured by Spectrum Medical Ltd and has received FDA 510(k) clearance with decision code SESE. It is classified as a Class II device under product code DWA. The device is used to drive the Quantum CP22 or CP20 systems and is supplied with specific model numbers including K192838.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK192838 Date13 Apr 2020ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 23 Oct 2026)

Specification

510(k)

Full name
Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure
510(k) Number
FDA Product Code
DWA
FDA applicant
Spectrum Medical , Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.4380
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Spectrum Medical Ltd

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Questions

  • What is the Quantumn Centrifugal Drive used for?

    The Quantumn Centrifugal Drive is a control device used to regulate pump speed during cardiopulmonary bypass procedures. It is designed to drive the Quantum CP22 or CP20 systems and comes in high pressure and medium pressure configurations to meet different clinical needs.

  • What are the differences between the high pressure and medium pressure versions?

    The high pressure version processes data at a faster rate, while the medium pressure version processes data at a slower rate, making it better suited for routine monitoring and checkups. Both versions provide efficient and reliable data for cardiopulmonary bypass procedures.

  • How is the Quantumn Centrifugal Drive supplied?

    The device is supplied with specific model numbers including K192838. It is manufactured by Spectrum Medical Ltd and is designed to be used with the Quantum CP22 or CP20 systems for cardiopulmonary bypass procedures.

  • What is the regulatory status of the Quantumn Centrifugal Drive?

    The Quantumn Centrifugal Drive has received FDA 510(k) clearance with decision code SESE. It is classified as a Class II device under product code DWA and is manufactured by Spectrum Medical Ltd.