Spectrum Medical Inc
FDA Regulatory Profile
Spectrum Medical Inc appears in FDA public data with 5 recalls — including 1 Class I (most serious) —, 23 510(k) clearances, 4 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1695-2025, Class II) was initiated on March 19, 2025. Its most recent 510(k) clearance was granted on March 12, 2026.
Summary
- Total Recalls
- 5 (1 Class I)
- 510(k) Clearances
- 23
- Inspections
- 4
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1695-2025 | Class II | Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrh | March 19, 2025 |
| Z-1696-2025 | Class II | Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient ( | March 19, 2025 |
| Z-1327-2025 | Class II | Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pum | January 16, 2025 |
| Z-0224-2025 | Class II | Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the v | March 13, 2023 |
| Z-2238-2019 | Class I | Quantum Pump Console | May 29, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K240934 | Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC V | March 12, 2026 |
| K252541 | Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W | March 12, 2026 |
| K251762 | Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) | August 4, 2025 |
| K240908 | Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) | July 8, 2025 |
| K250326 | Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) | 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 |
| K202557 | Quantum Workstation 12 Elite | October 2, 2020 |
| K192838 | Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure | April 13, 2020 |
| K190282 | Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) | May 24, 2019 |
| K181942 | Quantum Ventilation Module | October 18, 2018 |
| K181923 | Quantum Workstation 12.1 | August 17, 2018 |
| K173834 | Quantum Pump Console | May 25, 2018 |
| K173591 | Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas | March 28, 2018 |
| K163657 | Quantum Workstation | January 18, 2017 |
| K110957 | M4 MONITOR | May 31, 2011 |
| K091908 | M3 MONITOR | July 10, 2009 |