Company ยท GB
Spectrum Medical , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2025. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
7recalls (2 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 7 |
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 4 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 3 |
| DTX | Gas Control Unit, Cardiopulmonary Bypass | 3 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 2 |
| DWA | Control, Pump Speed, Cardiopulmonary Bypass | 1 |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | 1 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 8, 2025 | K240908 | Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) Spectrum Medical , Ltd., GB | DTR |
| May 6, 2022 | K212657 | Quantum Heater-Cooler Spectrum Medical , Ltd., GB | DWC |
| May 4, 2021 | K210669 | Quantum Mini Ventilation Module Spectrum Medical , Ltd., GB | DTX |
| Oct 16, 2020 | K202733 | Quantum Ventilation Module Spectrum Medical , Ltd., GB | DTX |
| Oct 2, 2020 | K202557 | Quantum Workstation 12 Elite Spectrum Medical , Ltd., GB | DRY |
| Apr 13, 2020 | K192838 | Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure Spectrum Medical , Ltd., GB | DWA |
| May 24, 2019 | K190282 | Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) Spectrum Medical , Ltd., GB | DTQ |
| Oct 18, 2018 | K181942 | Quantum Ventilation Module Spectrum Medical , Ltd., GB | DTX |
| Aug 17, 2018 | K181923 | Quantum Workstation 12.1 Spectrum Medical , Ltd., GB | DRY |
| May 25, 2018 | K173834 | Quantum Pump Console Spectrum Medical , Ltd., GB | DTQ |
| Mar 28, 2018 | K173591 | Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas Spectrum Medical , Ltd., GB | DRY |
| Jan 18, 2017 | K163657 | Quantum Workstation Spectrum Medical , Ltd., GB | DRY |
| Jul 10, 2009 | K091908 | M3 MONITOR Spectrum Medical , Ltd., GB | DRY |
| Aug 17, 2007 | K072131 | M3 MONITOR Spectrum Medical , Ltd., GB | DRY |
| Jul 11, 2007 | K071725 | M2 MONITOR Spectrum Medical , Ltd., GB | DRY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2026 | SPECTRUM MEDICAL SRL Brand Name: Quantum PureFlow
Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8
Model/Catalog Number: HX55W-S0
Software Version: N/A
Product Description: The Quantum PureFlow Standar Open, Classified |
DTR | K220110 K223879 |
| Sep 29, 2026 | SPECTRUM MEDICAL SRL Brand Name: Quantum PureFlow
Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W
Model/Catalog Number: HX55V-S0W
Software Version: N/A
Product Description: The Quantum PureFlow Stan Open, Classified |
DTR | K220110 K223879 |
| Apr 29, 2025 | Spectrum Medical Ltd. Brand Name: Quantum Informatics - VISION / LIVE VUE
Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms)
Product Description: VISION / LIVE VUE is a software-only dev Open, Classified |
MWI | None listed |
| Apr 29, 2025 | Spectrum Medical Ltd. Brand Name: Quantum Informatics - VIPER
Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms)
Product Description: VIPER is a software-only device (SaMD) that is inten Open, Classified |
MWI | None listed |
| Mar 13, 2025 | Spectrum Medical Inc Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors
Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Model/Catalog Number: CP22V-VT
Software Version: N/ Open, Classified |
KFM | K201320 |
| Oct 24, 2024 | Spectrum Medical Ltd. Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00 Completed |
DTQ | K173834 |
| Aug 23, 2019 | Spectrum Medical Ltd. Quantum Pump Console Terminated |
DTQ | K173834 |