Home / 510(k) Clearances / K202557

510(k) K202557

Quantum Workstation 12 Elite by Spectrum Medical , Ltd. — Product Code DRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2020
Date Received
September 3, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4330
Review Panel
CV
Submission Type

Other clearances by Spectrum Medical , Ltd.

  • K252541 — Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W (March 12, 2026)
  • K240934 — Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Bl (March 12, 2026)
  • K251762 — Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-N (August 4, 2025)
  • K240908 — Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery (July 8, 2025)
  • K250326 — Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-N (June 24, 2025)
  • K241206 — Quantum Perfusion Hybrid System (July 18, 2024)
  • K241248 — Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) (May 31, 2024)
  • K212657 — Quantum Heater-Cooler (May 6, 2022)
  • K210669 — Quantum Mini Ventilation Module (May 4, 2021)
  • K202733 — Quantum Ventilation Module (October 16, 2020)

Other clearances for product code DRY

  • K234065 — CDI OneView Monitoring System (April 25, 2024)
  • K202154 — B-Capta (April 1, 2021)
  • K182110 — CDI Blood Parameter Monitoring System 550 (November 2, 2018)
  • K181923 — Quantum Workstation 12.1 (August 17, 2018)
  • K173591 — Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas (March 28, 2018)
  • K163657 — Quantum Workstation (January 18, 2017)
  • K133157 — TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURF (October 23, 2014)
  • K133658 — CDI BLOOD PARAMETER MONITORING SYSTEM 500 (July 25, 2014)
  • K123039 — CDI BLOOD PARAMETER MONITORING SYSTEM 500 (November 20, 2012)
  • K110957 — M4 MONITOR (May 31, 2011)