FDA product code KFM: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
KFM is the FDA product code for pump, blood, cardiopulmonary bypass, non-roller type. It is a Class II device, regulated under 21 CFR 870.4360 and reviewed by the Cardiovascular panel. FDA has cleared 84 510(k) submissions under KFM, 5 in the last five years, from 41 different applicants. The average 510(k) review took 170 days (median 123); 98 days on average over the last three years. FDA has posted 40 recalls for KFM devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type |
| Device class | Class II |
| Regulation | 21 CFR 870.4360 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for KFM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 345 |
| 2019 | 3 | 156 |
| 2020 | 3 | 84 |
| 2021 | 3 | 547 |
| 2023 | 3 | 156 |
| 2025 | 2 | 98 |
Compare with all 510(k) review times · Search every KFM clearance
Top KFM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic, Inc. | 7 | 2020-05-21 |
| Qura S.R.L | 5 | 2023-10-26 |
| Maquet Cardiopulmonary, AG | 5 | 2013-11-12 |
| Cardiacassist, Inc. | 4 | 2023-08-03 |
| Abiomed, Inc. | 4 | 2011-04-27 |
36 more applicants have KFM clearances. See the full list in Caduvo.
Most recent KFM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251762 | Spectrum Medical S.R.L. | Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) | 2025-08-04 | 56 |
| K250326 | Spectrum Medical S.R.L. | Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) | 2025-06-24 | 139 |
| K233091 | Qura S.R.L | Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT) | 2023-10-26 | 30 |
| K232132 | Cardiacassist, Inc. | LifeSPARC System | 2023-08-03 | 16 |
| K220842 | Qura S.R.L | Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors | 2023-05-19 | 422 |
Recalls for KFM devices
40 product recalls in 23 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2025-01-16.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 3 |
| 2020 | 9 |
| 2021 | 1 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code KFM?
KFM is the FDA product code for pump, blood, cardiopulmonary bypass, non-roller type. It is a Class II device, regulated under 21 CFR 870.4360 and reviewed by the Cardiovascular panel.
What device class is KFM?
Class II, regulation 21 CFR 870.4360. Typical premarket route: 510(k).
How long does a 510(k) take for product code KFM?
Across 84 cleared submissions the average was 170 days from receipt to decision (median 123).
Which companies have the most KFM clearances?
Medtronic, Inc. (7); Qura S.R.L (5); Maquet Cardiopulmonary, AG (5); Cardiacassist, Inc. (4); Abiomed, Inc. (4).
Have KFM devices been recalled?
Yes: 40 product recalls across 23 recall events; the most recent began 2025-01-16.
Next steps
- Run an FDA pathway report with predicate devices for product code KFM
- Run a recall and safety report across every KFM manufacturer
- Watch product code KFM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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