# K112628: Nipro Blood Tubing Set with Transducer Protector and Priming Set

- Pathway: 510(k) (Special)
- Applicant: Nipro Medical Corporation
- Decided: Sep 28, 2012 after 385 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: 2 generations back to K010264 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072024: Nipro Blood Tubing Set with Transducer Protector and Priming Set, Model A201-A219, V801-V806, 5M9634, 5M9693, Nipro Medical Corp. (2007) Summary page 1.

## Recalls of this device
- Mar 30, 2015 · Class II · Z-0624-2016: Blood foaming was found during evaluation of the product.

## Indications for use
The Nipro Set - SLIMLINE is a disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis.

Source page: https://510kreport.com/device/K112628
Methodology: https://510kreport.com/methodology