510(k) · Cleared
Clearedstay•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
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care Renal Therapies Group, LLC · KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Cleared on Apr 3, 2025 as substantially equivalent to K173593 (Fresenius Medical Care Renal Therapies Group, LLC, 2018) after a 50-day review. Its family tree reaches back 2 generations to 1990. 1 of the 4 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 3, 2025
- Review
- 50 days
- Class
- Class II
- Product code
- KDJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K896764 (1990). 3 ancestors in all. No later device cites it as a predicate yet. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK896764 Universal Connector Catalog NO. 48-1025-5National Medical Care, Medical Products Div., Inc. · 1990
- 1 generation backK173593 stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe…Fresenius Medical Care Renal Therapies Group, LLC · 2018 · Recalled (Class I)
- This deviceK250404 stay•safe® catheter extension set with Safe- Lock, 12 inch…Fresenius Medical Care Renal Therapies Group, LLC · 2025
Class I recalls in this family
- K173593 stay•safe catheter extension set with Safe-Lock…direct predicate · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K896764 | Universal Connector Catalog NO. 48-1025-5 | National Medical Care, Medical Products Div., Inc. | 1990 | — |
| −1 | K173593 | stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter… | Fresenius Medical Care Renal Therapies Group, LLC | 2018 | Class I |
| 0 (this device) | K250404 | stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe®… | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KDJ device
- #1 K231849 MiniCap Extended Life PD Transfer Set with…score 7.3 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K173593 | stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension…Summary page 5…inch, stay•safe® catheter extension set with Luer-Lock, 12 inch, stay•safe® catheter extension set with Luer-Lock, 18 inch, and stay•safe® to Luer-Lock adapter, 4 inch (K173593) are the legally marketed predicate devices.… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K173593stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6…Fresenius Medical Care Renal Therapies Group, LLC · 2018 · Direct predicate · ◆ on the line of descent in FIG. 15 Class I recalls
What does this lineage say?
- The line of descent spans 35 years and passes through 2 companies; a new generation was cleared every 28.2 years on median.
- 1 of the 3 ancestors has a recall of any class; 1 has a Class I recall.
How does its category compare?
All KDJ devicesKDJ Set, Administration, For Peritoneal Dialysis, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · KDJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KDJ
90in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KDJ
21in 2024
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · KDJ
2,460in 2025
MAUDE reports naming product code KDJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 219 |
| 2008 | 1 | — | 0 | 411 |
| 2009 | 0 | — | 2 | 233 |
| 2010 | 0 | — | 0 | 1,879 |
| 2011 | 0 | — | 0 | 4,315 |
| 2012 | 0 | — | 0 | 4,294 |
| 2013 | 1 | — | 1 | 5,623 |
| 2014 | 0 | — | 0 | 7,680 |
| 2015 | 2 | — | 1 | 6,870 |
| 2016 | 1 | — | 0 | 7,045 |
| 2017 | 0 | — | 0 | 4,636 |
| 2018 | 3 | 90 | 0 | 3,379 |
| 2019 | 1 | — | 0 | 2,456 |
| 2020 | 0 | — | 1 | 2,870 |
| 2021 | 0 | — | 0 | 3,167 |
| 2022 | 1 | — | 12 | 2,927 |
| 2023 | 0 | — | 1 | 2,947 |
| 2024 | 1 | — | 21 (10) | 3,113 |
| 2025 | 1 | — | 0 | 2,460 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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 stayssafe catheter extension set with Safe-Lock is used to connect a PD catheter with Safe-Lock compatible catheter adapter to PD systems that use stayssafe PIN technology. The stay+safe catheter extension set with Luer-Lock is indicated for use in…
Read the full statement (165 words)
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 stayssafe catheter extension set with Safe-Lock is used to connect a PD catheter with Safe-Lock compatible catheter adapter to PD systems that use stayssafe 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 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 stayssafe catheter extension set to medical devices with a Luer-Lock connection.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250404 · printed Nov 6, 2026
Cite this page
510(k) Report. “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.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250404
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026