KFM
- Product code
- KFM
- Device name
- Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.4360
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 84 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251762 | 2025-08-04 | Spectrum Medical S.R.L. | Quantum Perfusion Centrifugal Blood Pump CP20NG with… | |
| K250326 | 2025-06-24 | Spectrum Medical S.R.L. | Quantum Perfusion Centrifugal Blood Pump CP22NG with… | |
| K233091 | 2023-10-26 | Qura S.R.L | Quantum Perfusion Centrifugal Blood Pump CP37 with I… |
Official FDA classification page: KFM
Classification and pathway per current FDA publications. Data from openFDA (CC0).