# K173651: Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care Renal Therapies Group, LLC
- Decided: Feb 14, 2018 after 78 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: 2 generations back to K811986 (1981). 6 ancestors in all.
No later device cites it as a predicate yet.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041792: Fresenius Staysafe Patient Connectors, Model 050-87211, Fresenius Medical Care North America (2004) Summary page 4.
- K895991: Peritoneal Dialysis Drainage Set NO. 48-0025-6, National Medical Care, Medical Products Div., Inc. (1990) Summary page 10.

## Recalls of this device
- Apr 28, 2021 · Class II · Z-2089-2021: Exposed to freezing temperatures due to refrigerated truck malfunctions

## Indications for use
Multiple Tubing Segment (MTS) Set with stay•safe PIN Connectors: The Multiple Tubing Segment (MTS) Set with stay•safe PIN Connectors is indicated for use by patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The MTS Set is placed during set-up to make additional connections to the cycler set when prescribed or when an interruption in treatment is necessary. This device is compatible with stay•safe Peritoneal Dialysis (PD) connectology system and is to be used only with Fresenius Medical Care (FMCNA) Cyclers and Cycler Sets. stay•safe® Drain Set: The stay•safe Drain Set is indicated for use by patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay•safe Drain Set is used to connect directly to the stay•safe catheter extension set to enable drainage and/or effluent sampling as needed. This device is compatible with Fresenius Medical Care (FMCNA) Peritoneal Dialysis (PD) stay•safe catheter extension sets.

Source page: https://510kreport.com/device/K173651
Methodology: https://510kreport.com/methodology