# KFM: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

- Device class: 2; regulation: 21 CFR 870.4360; FDA's rule: 510(k) required
- FDA decisions: 84
- 510(k) review time 2021–2025: median 281 days (middle half 50–460)
- Recalls: 22 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2009: 5
- 2010: 3
- 2011: 7
- 2013: 2
- 2017: 1
- 2019: 3
- 2020: 3
- 2021: 3
- 2023: 3
- 2025: 2

## Most-cited predicates
- K020271: Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100 (2003), cited by 10
- K973011: BPX80 Bio-Pump (BPX80) (1998), cited by 10
- K991864: Rotaflow Centrifugal Pump System (2000), cited by 9
- K011835: Cobe Revolution (2002), cited by 4
- K061072: Rotaflow Centrifugal Pump with Safeline Coating, Model BSQ-RF-32 (2006), cited by 4
- K852698: Bio Medicus Bio Pump Model BP-80 (1985), cited by 4
- K852807: Bio Medicus Bio Pump Model BP-50 (1985), cited by 3
- K915363: Sarns 7850 Centrifugal Pump (Modified) (1993), cited by 3
- K100631: Affiity CP Centrifugal Blood Pump (2010), cited by 3
- K063723: Impella Recover LP 2.5 Percutaneous Cardiac Support System (2008), cited by 3

Source page: https://510kreport.com/product-code/KFM
Data by year (CSV): https://510kreport.com/product-code/KFM.csv