# K032975: JMS Blood Tubing Sets

- Pathway: 510(k) (Traditional)
- Applicant: Jms North America Corp.
- Decided: Aug 16, 2004 after 327 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: 1 generation back to K852605 (1985). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001971: Hemodialysis Tubing Sets, Ofi Biomedica S.P.A. (2001) Summary page 1.
- K852605: Blood Tubing Set, Medflex International, Inc. (1985) Summary page 1.
- K001107: Fresenius Combilines Low Volume Blood Tubing Set,  Models 03-2291 (Post Pump) and 03-2292 (Pre-Pump), Fresenius Medical Care North America (2000) Summary page 1.
- K953823: Arterial Venous Blood Tubing Set, Medisystems Corp. (1996) Summary page 1.

## Cited in the summary but kept off the family tree
- K010465: Denstat, Elmed, Inc. (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K171952: Dimesol Tubing Sets for Hemodialysis (2018), 0 descendants of its own

## Indications for use
The JMS Blood Tubing Sets with transducer protector and priming sets are disposable bloodlines intended to provide extracorporeal access to the patient's blood during hemodialysis.

Source page: https://510kreport.com/device/K032975
Methodology: https://510kreport.com/methodology