# K072024: Nipro Blood Tubing Set with Transducer Protector and Priming Set, Model A201-A219, V801-V806, 5M9634, 5M9693

- Pathway: 510(k) (Special)
- Applicant: Nipro Medical Corp.
- Decided: Oct 4, 2007 after 72 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010264 (2001). 1 ancestor in all.
16 later devices descend from it; 6 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010264: Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set, Nipro Medical Corp. (2001) Summary page 1.

## Most influential descendants
- K112314: Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 Hemodiafilter (2012), 5 descendants of its own
- K161582: DORA Tubing Sets for Hemodialysis (2017), 4 descendants of its own
- K231534: 5008X Hemodialysis System (2024), 2 descendants of its own
- K201866: NovaLine Tubing Sets for Hemodialysis (2021), 2 descendants of its own
- K243505: 5008X Hemodialysis System (2025), 1 descendant of its own

## Recalls of this device
- Dec 19, 2017 · Class II · Z-1876-2018: There is a possibility of the heparin line is occluded.

## Indications for use
The Nipro® Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal access to the patient's blood during Hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge.

Source page: https://510kreport.com/device/K072024
Methodology: https://510kreport.com/methodology