Skip to content

Quantum Workstation 12 Elite

by Spectrum Medical Ltd United Kingdom 510(k)

510(k) K202557 Product code DRY

Overview

The Quantum Workstation 12 Elite is a Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass device. It integrates two channels of flow measurement, four channels of pressure and temperature measurement, and non-invasive measurement of O2 Saturations and Hb/Hct. The device is used in cardiopulmonary bypass and ECMO procedures.

The Quantum Workstation 12 Elite is supplied with a product code of DRY and is classified as a class 2 device. It has been authorized with an FDA 510K clearance. The device is used in cardiovascular medical specialty and has a registration number. It is designed to offer clinical flexibility when supporting complex procedures.

Summary written by AI from registry data, 22 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK202557 Date2 Oct 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) · synced 23 Oct 2026

510(k) Number
FDA Product Code
DRY
FDA applicant
Spectrum Medical , Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.4330
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

From the manufacturer

The Quantum 12" Workstation Elite The Quantum Workstation integrates two channels of flow measurement, four channels of pressure and temperature measurement and Spectrum Medical's proven non-invasive measurement of O 2 Saturations and Hb/Hct.

Source: spectrummedical.com

The Quantum Workstation The revolutionary new range of Quantum Perfusion Systems from Spectrum Medical enhances patient and clinician safety during Cardiopulmonary Bypass and ECMO procedures. With a pioneering dedication to system modularity, Spectrum Medical can provide advanced customized Perfusion Systems for today's clinical best practice and the new best practices of the future.

Source: spectrummedical.com

Other devices from Spectrum Medical Ltd

See all devices from Spectrum Medical Ltd →

Questions

  • What is the Quantum Workstation 12 Elite used for?

    The Quantum Workstation 12 Elite is used in cardiopulmonary bypass and ECMO procedures to measure blood-gas, flow, pressure, and other vital signs, providing clinical flexibility in complex procedures.

  • Is the Quantum Workstation 12 Elite a single-use or reusable device?

    The device description does not specify whether the Quantum Workstation 12 Elite is single-use or reusable, but it is classified as a class 2 device with an FDA 510K clearance.

  • What measurements can the Quantum Workstation 12 Elite perform?

    The Quantum Workstation 12 Elite can perform two channels of flow measurement, four channels of pressure and temperature measurement, and non-invasive measurement of O2 Saturations and Hb/Hct.

  • What is the regulatory status of the Quantum Workstation 12 Elite?

    The Quantum Workstation 12 Elite has been authorized with an FDA 510K clearance, indicating that it is substantially equivalent to a predicate device.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K202557 24 fields · synced 23 Oct 2026