# CAC: Apparatus, Autotransfusion

- Device class: 2; regulation: 21 CFR 868.5830; FDA's rule: 510(k) required
- FDA decisions: 195
- 510(k) review time 2021–2025: median 117 days (middle half 67–174)
- Recalls: 102 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2014: 3
- 2016: 2
- 2017: 1
- 2018: 2
- 2019: 1
- 2020: 1
- 2021: 4
- 2022: 1
- 2023: 2
- 2024: 3

## Most-cited predicates
- K101586: Xtra Autotransfusion System (2010), cited by 4
- K982650: Autologous Blood Management System (Abms) (1998), cited by 3
- K910238: Portable Auto Transfusion System 500 (1991), cited by 3
- K911656: Pleur-Evac Plus Contin. Reinfus. & Autoinfus. Syst (1991), cited by 3
- K884844: Pleur-Evac (R) a-7002--Adult/Pediatric Drainage (1989), cited by 3
- K854301: Pleur-Evac II Autotransfusion System (1985), cited by 3
- K020647: Dideco Electa (2002), cited by 3
- K210176: FlowSaver Blood Filter (2021), cited by 2
- K812355: Ibm 2991 Blood Cell Processor Mod. 1 & 2 (1981), cited by 2
- K933625: Brat 2 Autologus Blood Salvage System (1993), cited by 2

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