# JQC: Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

- Device class: 1; regulation: 21 CFR 862.2050; FDA's rule: 510(k) exempt
- FDA decisions: 38
- Recalls: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1999: 1
- 2000: 1
- 2002: 1
- 2003: 3
- 2004: 1
- 2006: 1
- 2007: 2
- 2008: 1
- 2010: 1
- 2019: 1

## Most-cited predicates
- K052925: SMARTPREP2 Centrifuge System (2006), cited by 3
- K991430: Smartprep Centrifuge System (1999), cited by 3
- K994148: 3I Model (S)7426 and 7427 Celsep Centrifuge System (2000), cited by 2
- K021902: Magellan Autologus Platelet Separator, MAG100, Magellan Autologous Platelet Separator Deisposable Kit, MKT300 (2002), cited by 1

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