510(k) · Cleared
Recalled · Class I · 2024stay•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 May 21, 2018 as substantially equivalent to K920697 (National Medical Care, Medical Products Div., Inc., 1992) and 1 other predicate after a 181-day review. Its family tree reaches back 1 generation to 1990. 1 of the 4 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 5 times, including 5 Class I recalls.
- Decided
- May 21, 2018
- Review
- 181 days
- Class
- Class II
- Product code
- KDJ
- Recalls
- 5 (5 Class I)
- Predicates
- 2
Its longest line of descent runs back 1 generation to K896764 (1990). 2 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK896764 Universal Connector Catalog NO. 48-1025-5National Medical Care, Medical Products Div., Inc. · 1990
- This deviceK173593 stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe…Fresenius Medical Care Renal Therapies Group, LLC · 2018
- Descendant · cites it directly · 0 of its ownK250404 stay•safe® catheter extension set with Safe- Lock, 12 inch…Fresenius Medical Care Renal Therapies Group, LLC · 2025
Most influential descendants
Showing 1 of 1 · See all- K250404stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter…Fresenius Medical Care Renal Therapies Group, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K896764 | Universal Connector Catalog NO. 48-1025-5 | National Medical Care, Medical Products Div., Inc. | 1990 | — |
| 0 (this device) | K173593 | stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter… | Fresenius Medical Care Renal Therapies Group, LLC | 2018 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 K250404 stay•safe® catheter extension set with Safe-…score 9.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K920697 | Dextrolyte II Peritoneal Dialysis 48-3029-7 ClampSummary page 6…y 5.1.3. Legally Marketed Predicate Device The legally marketed predicate device is the Dextrolyte II Peritoneal Dialysis Catheter Extension Set with Roller Clamp (K920697). This predicate has not been subject to a design-related recall. The Fresenius CAPD stay•safe® Disposable Administration Sets wi… | 1992 |
| * | K896764 | Universal Connector Catalog NO. 48-1025-5Summary page 16…KDJ Classification Panel: Gastroenterology/Urology 5.3.3. Legally Marketed Predicate Device The legally marketed predicate device is the Universal Connector (K896764). This predicate has not been subject to a design-related recall. The Fresenius CAPD stay•safe® Disposable Administration Sets wi… | 1990 |
| † | K022412 | Fresenius Capd Stay.Safe Disposable Administration Sets with Stay.Safe Connector | 2003 |
| † | K041792 | Fresenius Staysafe Patient Connectors, Model 050-87211 | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250404 | stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter… | 2025 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 23, 2024 | Class I | Z-1323-2024 | Device Design | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. |
| Jan 23, 2024 | Class I | Z-1324-2024 | Device Design | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. |
| Jan 23, 2024 | Class I | Z-1326-2024 | Device Design | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. |
| Jan 23, 2024 | Class I | Z-1327-2024 | Device Design | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. |
| Jan 23, 2024 | Class I | Z-1325-2024 | Device Design | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K250404 (Fresenius Medical Care Renal Therapies Group, LLC, 2025) has gone furthest, with 0 descendants of its own.
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. 2018, 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 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…
Read the full statement (166 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 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.
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/K173593 · printed Nov 5, 2026
Cite this page
510(k) Report. “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.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K173593
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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