# K122913: Affinity Fusion Recirculation Line Model RCL841

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Oct 19, 2012 after 28 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K800178 (1980). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113845: Tubing, Conmnectors, and Accessories Wit Balance Biosurface, Medtronic, Inc. (2012) Summary page 2.

## Indications for use
The recirculation line is indicated for use in connecting tubing and/or devices during cardiopulmonary bypass procedures up to 6 hours in duration.

Source page: https://510kreport.com/device/K122913
Methodology: https://510kreport.com/methodology