# FLD: Apparatus, Hemoperfusion, Sorbent

- Device class: 2; regulation: 21 CFR 876.5870; FDA's rule: 510(k) required
- FDA decisions: 11
- Recalls: 5 (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)
- 1983: 1
- 1984: 1
- 1987: 1
- 1989: 1
- 1996: 1
- 1997: 1
- 1999: 2
- 2005: 1
- 2012: 1
- 2014: 1

## Most-cited predicates
- K953751: Biologic-DT System (1996), cited by 1
- K984546: Biologic-DT Machine, Model DT-1000 and Biologic-DT Treatment Kit, Model DT-1000-TK (1999), cited by 1
- K033262: Molecular Adsorbent Recirculating System (Mars) (2005), cited by 1

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