Submission Details
| 510(k) Number | K250326 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 05, 2025 |
| Decision Date | June 24, 2025 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)
Jun 2025
Decision
139d
Days
Class 2
Risk
About This 510(k) Submission
K250326 is an FDA 510(k) clearance for the Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG), a Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (Class II — Special Controls, product code KFM), submitted by Spectrum Medical S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on June 24, 2025, 139 days after receiving the submission on February 5, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4360.
Device Classification
| Product Code | KFM — Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4360 |
Manufacturer
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