# K001971: Hemodialysis Tubing Sets

- Pathway: 510(k) (Traditional)
- Applicant: Ofi Biomedica S.P.A.
- Decided: May 24, 2001 after 330 days
- Product code: FIB (Protector, Transducer, Dialysis)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K032975: JMS Blood Tubing Sets (2004), 1 descendant of its own
- K171952: Dimesol Tubing Sets for Hemodialysis (2018), 0 descendants of its own

Source page: https://510kreport.com/device/K001971
Methodology: https://510kreport.com/methodology