# K124024: Apd Luer-Lock Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Fresensius Medical Care North America
- Decided: Sep 19, 2013 after 265 days
- Product code: KDJ (Set, Administration, For Peritoneal Dialysis, Disposable)
- Device class: 2
- Regulation: 21 CFR 876.5630
- 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: 1 generation back to K896764 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896764: Universal Connector Catalog NO. 48-1025-5, National Medical Care, Medical Products Div., Inc. (1990) Summary page 2.

## Recalls of this device
- Apr 28, 2021 · Class II · Z-2088-2021: Exposed to freezing temperatures due to refrigerated truck malfunctions

## Indications for use
The Fresenius APD Luer-Lock Adapter is intended for use with an Automated Peritoneal Dialysis cycler for the exchange of peritoneal dialysis solution. The single-use device is designed to connect any Fresenius cycler set with a Safe-Lock® connector to a peritoneal dialysis solution bag equipped with a standard luer-lock connector.

Source page: https://510kreport.com/device/K124024
Methodology: https://510kreport.com/methodology