# K953823: Arterial Venous Blood Tubing Set

- Pathway: 510(k) (Traditional)
- Applicant: Medisystems Corp.
- Decided: Sep 23, 1996 after 405 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
No predicates in its family tree.
14 later devices descend from it; 3 cite it directly.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Medisystems blood tubing sets: named in the summary without a submission number

## Most influential descendants
- K080807: Blood Tubing Sets (Sterile Fluid Path) (2008), 9 descendants of its own
- K994306: Reverso (2000), 9 descendants of its own
- K022536: \Resenius Access Flow Reserving Connectors, Fresenius Standalone Accces Flow Reserving Connector (2002), 7 descendants of its own
- K172238: CAREline Airless Hemodialysis Blood Tubing Sets (2017), 6 descendants of its own
- K201207: CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line (2020), 5 descendants of its own

## Indications for use
The blood tubing sets are intended for use with a blood access device and a medically approved flow-through treatment device.

Source page: https://510kreport.com/device/K953823
Methodology: https://510kreport.com/methodology