# K041792: Fresenius Staysafe Patient Connectors, Model 050-87211

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care North America
- Decided: Sep 24, 2004 after 84 days
- Product code: KDJ (Set, Administration, For Peritoneal Dialysis, Disposable)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K811986 (1981). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K811986: The Amp 80/2 Pediatric Cycler System, American Medical Products, Inc. (1981) Summary page 1.
- K022412: Fresenius Capd Stay.Safe Disposable Administration Sets with Stay.Safe Connector, Fresenius Medical Care North America (2003) Summary page 1.
- K904806: Capd Safelock Transfer Set W/Pre-Filled Connector, Fresenius USA, Inc. (1991) Summary page 1.
- K900106: Closed Disconnect System, Delmed, Inc. (1990) Summary page 1.

## Most influential descendants
- K173651: Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set (2018), 0 descendants of its own

## Indications for use
The Fresenius StaySafe Patient Connectors are intended for use with a peritoneal cycler for drainage and infusion of PD solution during a peritoneal dialysis exchanges. The Fresenius StaySafe Patient Connectors are indicated for use in acute and chronic peritoneal dialysis.

Source page: https://510kreport.com/device/K041792
Methodology: https://510kreport.com/methodology