Spectrum Medical Inc
GLOUCESTER Gloucestershire, GB
SPECTRUM MEDICAL INC appears in FDA device records in GLOUCESTER Gloucestershire, GB. FDA records list 38 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Spectrum Medical Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Qura S.R.L510(k), recall
510(k) clearance history
FDA records hold 38 510(k) clearances for Spectrum Medical Inc between 2006 and 2026. The busiest year on record is 2022, with 6. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2007 | 2 |
| 2009 | 1 |
| 2011 | 1 |
| 2017 | 1 |
| 2018 | 4 |
| 2019 | 1 |
| 2020 | 5 |
| 2021 | 5 |
| 2022 | 6 |
| 2023 | 3 |
| 2024 | 3 |
| 2025 | 3 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252541 | Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W | DTR | Substantially Equivalent | |
| K240934 | Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3); | DTZ | Substantially Equivalent | |
| K251762 | Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) | KFM | Substantially Equivalent | |
| K240908 | Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) | DTR | Substantially Equivalent | |
| K250326 | Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) | KFM | Substantially Equivalent | |
| K231982 | Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 | DTZ | Substantially Equivalent | |
| K241206 | Quantum Perfusion Hybrid System | DTN | Substantially Equivalent | |
| K241248 | Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) | DWF | Substantially Equivalent | |
| K231773 | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U | DTZ | Substantially Equivalent | |
| K233091 | Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT) | KFM | Substantially Equivalent | |
| K220842 | Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors | KFM | Substantially Equivalent | |
| K221353 | Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VS | DWF | Substantially Equivalent | |
| K213540 | Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set | DWF | Substantially Equivalent | |
| K220110 | Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger | DTR | Substantially Equivalent | |
| K212657 | Quantum Heater-Cooler | DWC | Substantially Equivalent | |
| K212341 | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U | DTZ | Substantially Equivalent | |
| K212688 | Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger | DTR | Substantially Equivalent | |
| K203424 | Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2 | DTZ | Substantially Equivalent | |
| K203067 | Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F | DWF | Substantially Equivalent | |
| K201320 | Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor | KFM | Substantially Equivalent | |
| K203057 | Quantum Perfusion Arterial Cannula Graft | DWF | Substantially Equivalent | |
| K210669 | Quantum Mini Ventilation Module | DTX | Substantially Equivalent | |
| K202733 | Quantum Ventilation Module | DTX | Substantially Equivalent | |
| K202557 | Quantum Workstation 12 Elite | DRY | Substantially Equivalent | |
| K202169 | Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 | KFM | Substantially Equivalent | |
| K192850 | Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 | KFM | Substantially Equivalent | |
| K192838 | Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure | DWA | Substantially Equivalent | |
| K190282 | Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) | DTQ | Substantially Equivalent | |
| K181942 | Quantum Ventilation Module | DTX | Substantially Equivalent | |
| K181923 | Quantum Workstation 12.1 | DRY | Substantially Equivalent | |
| K173834 | Quantum Pump Console | DTQ | Substantially Equivalent | |
| K173591 | Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas | DRY | Substantially Equivalent | |
| K163657 | Quantum Workstation | DRY | Substantially Equivalent | |
| K110957 | M4 MONITOR | DRY | Substantially Equivalent | |
| K091908 | M3 MONITOR | DRY | Substantially Equivalent | |
| K072131 | M3 MONITOR | DRY | Substantially Equivalent | |
| K071725 | M2 MONITOR | DRY | Substantially Equivalent | |
| K062468 | SPECTRUM M2 MONITOR | DRY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006126428 | 3006126428 | SPECTRUM MEDICAL INC | 481 Munn Road, Suite 180, Fort Mill, SC 29715 US | 2026 | No device listings on this registration |
| 3006073153 | 3006073153 | SPECTRUM MEDICAL LTD | Ashville Business Park, GLOUCESTER Gloucestershire GL2 9SL GB | 2026 | |
| 3016746283 | 3016746283 | SPECTRUM MEDICAL SRL | Via di Mezzo, 23, Mirandola Modena 41037 IT | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KRIAccessory Equipment, Cardiopulmonary Bypass
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass
- DWAControl, Pump Speed, Cardiopulmonary Bypass
- DWCController, Temperature, Cardiopulmonary Bypass
- DTXGas Control Unit, Cardiopulmonary Bypass
- DTRHeat-Exchanger, Cardiopulmonary Bypass
- OUGMedical Device Data System
- DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- DTZOxygenator, Cardiopulmonary Bypass
- KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- DTNReservoir, Blood, Cardiopulmonary Bypass
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1696-2025 | 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 device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VISION / LIVE VUE integrates multiple information feeds that supports remote monitoring of near real-time critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, critical care scoring systems, and sophisticated alerting systems, VISION / LIVE VUE offers improved support for ensuring compliance to hospital-specific protocols. The software solution also allows for big data queries, routine reporting, and review of quality performance metrics. | Medical device software marketed without FDA clearance . | Class II | Open, Classified | |
| Z-1695-2025 | 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 intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VIPER integrates multiple information feeds that supports the real-time distribution of critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, complication, and sophisticated alerting systems, VIPER offers improved support for the avoidance of adverse events. | Medical device software marketed without FDA clearance . | Class II | Open, Classified | |
| Z-1327-2025 | 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/A | Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures. | Class II | Open, Classified | |
| Z-0224-2025 | 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 | The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock. | Class II | Completed | |
| Z-2277-2021 | Spectrum Medical Quantum Standard heat exchanger | Product labeled as sterile may not have been adequately sterilized. In addition, these devices were imported to the US distributor, but the devices are not 510(k) cleared in the US. | Class II | Terminated | |
| Z-2238-2019 | Quantum Pump Console | Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use. | Class I | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain