Data / Medical devices / United Kingdom / Spectrum Medical Ltd
Spectrum Medical Ltd: FDA-registered device maker in GLOUCESTER Gloucestershire, United Kingdom, 14 510(k) clearances
Spectrum Medical Ltd is registered with the FDA (registration 3006073153) in GLOUCESTER Gloucestershire, United Kingdom. It lists 9 device types. The FDA files 14 510(k) clearances under its listings, the newest dated July 8, 2025. 3 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006073153
- Address
- Ashville Business Park Commerce Road, GLOUCESTER Gloucestershire, United Kingdom, GL2 9SL
- Owner or operator
- SPECTRUM MEDICAL LTD (9094087)
- Roles
- Manufacturer
- First device listed
- October 30, 2006
- Registered through
- 2027
- Brand names listed
- M4, Quantum Centrifugal Drive QCD22, Quantum Centrifugal Drive QCD37, Quantum Diagnostic Module 1, Quantum Diagnostic Module 2, Quantum Light - SAP Type 1, Quantum Light - SAP Type 3, Quantum Micro-Cardioplegia Delivery Module and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory Equipment, Cardiopulmonary Bypass | KRI | 1 | Manufacturer | accessdata.fda.gov |
| Console, Heart-Lung Machine, Cardiopulmonary Bypass | DTQ | 2 | Manufacturer | accessdata.fda.gov |
| Control, Pump Speed, Cardiopulmonary Bypass | DWA | 2 | Manufacturer | accessdata.fda.gov |
| Controller, Temperature, Cardiopulmonary Bypass | DWC | 2 | Manufacturer | accessdata.fda.gov |
| Gas Control Unit, Cardiopulmonary Bypass | DTX | 2 | Manufacturer | accessdata.fda.gov |
| Heat-Exchanger, Cardiopulmonary Bypass | DTR | 2 | Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | DRY | 2 | Manufacturer | accessdata.fda.gov |
| Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | KFM | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 8, 2025 | K240908 | Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) | DTR | Substantially Equivalent | Spectrum Medical , Ltd. | accessdata.fda.gov |
| May 6, 2022 | K212657 | Quantum Heater-Cooler | DWC | Substantially Equivalent | Spectrum Medical , Ltd. | accessdata.fda.gov |
| May 4, 2021 | K210669 | Quantum Mini Ventilation Module | DTX | Substantially Equivalent | Spectrum Medical , Ltd. | accessdata.fda.gov |
| October 16, 2020 | K202733 | Quantum Ventilation Module | DTX | Substantially Equivalent | Spectrum Medical , Ltd. | accessdata.fda.gov |
| October 2, 2020 | K202557 | Quantum Workstation 12 Elite | DRY | Substantially Equivalent | Spectrum Medical , Ltd. | accessdata.fda.gov |
| April 13, 2020 | K192838 | Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure | DWA | Substantially Equivalent | Spectrum Medical , Ltd. | accessdata.fda.gov |
| May 24, 2019 | K190282 | Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) | DTQ | Substantially Equivalent | Spectrum Medical , Ltd. | accessdata.fda.gov |
| October 18, 2018 | K181942 | Quantum Ventilation Module | DTX | Substantially Equivalent | Spectrum Medical , Ltd. | accessdata.fda.gov |
| August 17, 2018 | K181923 | Quantum Workstation 12.1 | DRY | Substantially Equivalent | Spectrum Medical , Ltd. | accessdata.fda.gov |
| May 25, 2018 | K173834 | Quantum Pump Console | DTQ | Substantially Equivalent | Spectrum Medical , Ltd. | accessdata.fda.gov |
| March 28, 2018 | K173591 | Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas | DRY | Substantially Equivalent | Spectrum Medical , Ltd. | accessdata.fda.gov |
| January 18, 2017 | K163657 | Quantum Workstation | DRY | Substantially Equivalent | Spectrum Medical , Ltd. | accessdata.fda.gov |
| May 31, 2011 | K110957 | M4 MONITOR | DRY | Substantially Equivalent | Spectrum Medical, Llp | accessdata.fda.gov |
| July 11, 2007 | K071725 | M2 MONITOR | DRY | Substantially Equivalent | Spectrum Medical , Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 19, 2025 | 96616 | Class II | Ongoing | 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 | Medical device software marketed without FDA clearance. | accessdata.fda.gov |
| March 13, 2023 | 95428 | Class II | Completed | 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. | accessdata.fda.gov |
| May 29, 2019 | 83352 | Class I | Terminated | Quantum Pump Console | Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use. | accessdata.fda.gov |
Compare with other makers
- All makers of Control, Pump Speed, Cardiopulmonary Bypass
- All makers of Console, Heart-Lung Machine, Cardiopulmonary Bypass
- All makers of Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- All makers of Medical Device Data System
- All makers of Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- All makers of Gas Control Unit, Cardiopulmonary Bypass
Updated July 8, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.