# K120823: BVM Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care North America, Design Cente
- Decided: Jun 15, 2012 after 88 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 K010264 (2001). 2 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082719: Nikkline Blood Tubing Lines with Transducer Protectors, Models AV06A-P, AVO6B-P, AV06C-P, Nikkiso CO., LTD. (2009) Summary page 1.

## Most influential descendants
- K140841: Tablo Cartridge (2014), 7 descendants of its own
- K193670: SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set (2020), 3 descendants of its own
- K210661: SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset (2021), 2 descendants of its own
- K190793: Tablo Hemodialysis System, Tablo Cartridge (2019), 2 descendants of its own
- K210782: Tablo Cartridge (2021), 1 descendant of its own

## Indications for use
The Blood Volume Monitor (BVMV) Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The set is intended for use with a prescribed hemodialyzer. The BVMV.Hemodlialysis Blood Tubing Set is intended for acute and chronic hemodialysis therapy. The set is intended for use with the Fresenius 2008 Series Hemodialysis Machines equipped with a BVM Module for monitoring patient blood volume during hemodialysis.

Source page: https://510kreport.com/device/K120823
Methodology: https://510kreport.com/methodology