# K022536: \Resenius Access Flow Reserving Connectors, Fresenius Standalone Accces Flow Reserving Connector

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care
- Decided: Oct 30, 2002 after 90 days
- Product code: KOC (Accessories, Blood Circuit, Hemodialysis)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K953823 (1996). 2 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994306: Reverso, Medisystems Corp. (2000) Summary page 1.

## Most influential descendants
- 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
- K231534: 5008X Hemodialysis System (2024), 2 descendants of its own
- K243505: 5008X Hemodialysis System (2025), 1 descendant of its own
- K213992: CombiSet Hemodialysis Blood Tubing Set (2023), 1 descendant of its own

## Recalls of this device
- Dec 19, 2014 · Class II · Z-1047-2015: Potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope
- Nov 25, 2008 · Not classified · Z-0859-2009: Port may crack and separate resulting in potential blood exposure/blood loss for the patient
- Nov 25, 2008 · Not classified · Z-0860-2009: Port may crack and separate resulting in potential blood exposure/blood loss for the patient

## Indications for use
The Fresenius Access Flow Reversing Connector (AFRC) is for use during hemodialysis to reverse the blood flow to and from the arterial and venous vascular access devices during hemodialysis in order to obtain an access flow measurement. The AFRC facilitates the test procedure by eliminating the need to disconnect bloodlines during the test procedure. It may be used in conjunction with access devices, such as; the Fresenius Online Clearance Monitor, the CritLine@from HemaMetrics, or the HDO 1 Hemodialysis Monitor from Transonic Systems when flow reversal is required.

Source page: https://510kreport.com/device/K022536
Methodology: https://510kreport.com/methodology