# K173593: stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inch

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care Renal Therapies Group, LLC
- Decided: May 21, 2018 after 181 days
- Product code: KDJ (Set, Administration, For Peritoneal Dialysis, Disposable)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: 5 (5 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). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920697: Dextrolyte II Peritoneal Dialysis 48-3029-7 Clamp, National Medical Care, Medical Products Div., Inc. (1992) Summary page 6.
- K896764: Universal Connector Catalog NO. 48-1025-5, National Medical Care, Medical Products Div., Inc. (1990) Summary page 16.

## Most influential descendants
- K250404: stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inch (2025), 0 descendants of its own

## Recalls of this device
- Jan 23, 2024 · Class I · Z-1323-2024: The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
- Jan 23, 2024 · Class I · Z-1324-2024: The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
- Jan 23, 2024 · Class I · Z-1326-2024: The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
- Jan 23, 2024 · Class I · Z-1327-2024: The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
- Jan 23, 2024 · Class I · Z-1325-2024: The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

## Indications for use
The stay•safe catheter extension set with Safe-Lock is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay•safe catheter extension set with Safe-Lock is used to connect a PD catheter with Safe-Lock compatible catheter adapter to PD systems that use stay•safe PIN technology. The stay•safe catheter extension set with Luer-Lock is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay•safe catheter extension set with Luer-Lock is used to connect a PD catheter with a Luer-Lock catheter adapter to PD systems that use stay•safe PIN technology. The stay•safe to Luer-Lock adapter is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay•safe to Luer-Lock adapter is used to connect a stay•safe catheter extension set to medical devices with a Luer-Lock connection.

Source page: https://510kreport.com/device/K173593
Methodology: https://510kreport.com/methodology