# K090255: Blood Tubing Sets (Sterile Fluid Path)

- Pathway: 510(k) (Special)
- Applicant: Nxstage Medical, Inc.
- Decided: Feb 10, 2009 after 8 days
- Product code: FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve)
- 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
Longest line of descent: 2 generations back to K953823 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080807: Blood Tubing Sets (Sterile Fluid Path), Nxstage Medical, Inc. (2008) Summary page 2.

## Indications for use
The blood tubing sets are indicated for use with a medically prescribed hemodialyzer. The suitability of a particular configuration is the responsibility of the physician in charge.

Source page: https://510kreport.com/device/K090255
Methodology: https://510kreport.com/methodology