Submission Details
| 510(k) Number | K251762 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 09, 2025 |
| Decision Date | August 04, 2025 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)
Aug 2025
Decision
56d
Days
Class 2
Risk
About This 510(k) Submission
K251762 is an FDA 510(k) clearance for the Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-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 August 4, 2025, 56 days after receiving the submission on June 9, 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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