Data / Medical devices / Italy / Spectrum Medical SRL
Spectrum Medical SRL: FDA-registered device maker in Mirandola Modena, Italy, 20 510(k) clearances
Spectrum Medical SRL is registered with the FDA (registration 3016746283) in Mirandola Modena, Italy. It lists 6 device types. The FDA files 20 510(k) clearances under its listings, the newest dated March 12, 2026. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3016746283
- Address
- Via di Mezzo, 23, Mirandola Modena, Italy, 41037
- Owner or operator
- Spectrum Medical SRL (10069754)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- October 12, 2020
- Registered through
- 2027
- Brand names listed
- KIT CPC - Barbed Connector Adaptor, KIT CPC - Hansen Connector Adaptor, KIT QUANTUM SUPERPAC TUBING SET, QUANTUM PERFUSION BLOOD OXYGENATOR VT160-E3, QUANTUM PERFUSION BLOOD OXYGENATOR VT200-E3, QUANTUM PERFUSION BLOOD OXYGENATOR VT75-E1, QUANTUM PERFUSION BLOOD OXYGENATOR VT75-E2, QUANTUM PERFUSION BLOOD OXYGENATOR VT75-E3 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory Equipment, Cardiopulmonary Bypass | KRI | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | 2 | Manufacturer | accessdata.fda.gov |
| Heat-Exchanger, Cardiopulmonary Bypass | DTR | 2 | Manufacturer | accessdata.fda.gov |
| Oxygenator, Cardiopulmonary Bypass | DTZ | 2 | Manufacturer | accessdata.fda.gov |
| Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | KFM | 2 | Manufacturer | accessdata.fda.gov |
| Reservoir, Blood, Cardiopulmonary Bypass | DTN | 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 |
|---|---|---|---|---|---|---|
| March 12, 2026 | K252541 | Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W | DTR | Substantially Equivalent | Spectrum Medical S.R.L. | accessdata.fda.gov |
| March 12, 2026 | 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 | Spectrum Medical S.R.L. | accessdata.fda.gov |
| August 4, 2025 | K251762 | Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) | KFM | Substantially Equivalent | Spectrum Medical S.R.L. | accessdata.fda.gov |
| June 24, 2025 | K250326 | Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) | KFM | Substantially Equivalent | Spectrum Medical S.R.L. | accessdata.fda.gov |
| September 12, 2024 | K231982 | Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 | DTZ | Substantially Equivalent | Qura S.R.L | accessdata.fda.gov |
| July 18, 2024 | K241206 | Quantum Perfusion Hybrid System | DTN | Substantially Equivalent | Spectrum Medical S.R.L. | accessdata.fda.gov |
| May 31, 2024 | K241248 | Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) | DWF | Substantially Equivalent | Spectrum Medical S.R.L. | accessdata.fda.gov |
| November 8, 2023 | 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 | Qura S.R.L | accessdata.fda.gov |
| October 26, 2023 | 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 | Qura S.R.L | accessdata.fda.gov |
| May 19, 2023 | K220842 | Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors | KFM | Substantially Equivalent | Qura S.R.L | accessdata.fda.gov |
| April 13, 2023 | K223879 | Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) | DTR | Substantially Equivalent | Quara S.R.L. | accessdata.fda.gov |
| August 18, 2022 | 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 | Qura S.R.L | accessdata.fda.gov |
| May 20, 2022 | K213540 | Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set | DWF | Substantially Equivalent | Qura S.R.L | accessdata.fda.gov |
| May 6, 2022 | K220110 | Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger | DTR | Substantially Equivalent | Qura S.R.L | accessdata.fda.gov |
| January 28, 2022 | 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 | Qura S.R.L | accessdata.fda.gov |
| December 17, 2021 | 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 | Qura S.R.L | accessdata.fda.gov |
| November 8, 2021 | 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 | Qura S.R.L | accessdata.fda.gov |
| November 3, 2021 | K201320 | Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor | KFM | Substantially Equivalent | Qura S.R.L | accessdata.fda.gov |
| June 30, 2021 | K203057 | Quantum Perfusion Arterial Cannula Graft | DWF | Substantially Equivalent | Qura S.R.L | accessdata.fda.gov |
| September 2, 2020 | K202169 | Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 | KFM | Substantially Equivalent | Qura S.R.L | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 17, 2026 | 99462 | Class II | Ongoing | 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 Standard Heat Exchanger | Due to blood-to-glycol leak in the heat exchanger. | accessdata.fda.gov |
| March 22, 2021 | 88267 | Class II | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Oxygenator, Cardiopulmonary Bypass
- All makers of Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- All makers of Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- All makers of Heat-Exchanger, Cardiopulmonary Bypass
- All makers of Reservoir, Blood, Cardiopulmonary Bypass
- All makers of Accessory Equipment, Cardiopulmonary Bypass
Updated September 29, 2026. 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.