510(k) · Cleared
Recalled · Class II · 2021Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set
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 Feb 14, 2018 as substantially equivalent to K041792 (Fresenius Medical Care North America, 2004) and 1 other predicate after a 78-day review. Its family tree reaches back 2 generations to 1981. 1 of the 7 devices in its family, counting itself, has a Class I recall. It has been recalled once.
- Decided
- Feb 14, 2018
- Review
- 78 days
- Class
- Class II
- Product code
- KDJ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K811986 (1981). 6 ancestors in all. No later device cites it as a predicate yet. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK811986 The Amp 80/2 Pediatric Cycler SystemAmerican Medical Products, Inc. · 1981
- 1 generation backK041792 Fresenius Staysafe Patient Connectors, Model 050-87211Fresenius Medical Care North America · 2004
- This deviceK173651 Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe…Fresenius Medical Care Renal Therapies Group, LLC · 2018
Class I recalls in this family
- K022412 Fresenius Capd Stay.Safe Disposable…2 generations back · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K811986 | The Amp 80/2 Pediatric Cycler System | American Medical Products, Inc. | 1981 | — |
| −1 | K041792 | Fresenius Staysafe Patient Connectors, Model 050-87211 | Fresenius Medical Care North America | 2004 | — |
| 0 (this device) | K173651 | Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set | Fresenius Medical Care Renal Therapies Group, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 2003 | 1 | 1 |
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 |
|---|---|---|---|
| * | K041792 | Fresenius Staysafe Patient Connectors, Model 050-87211Summary page 4…n Panel: Gastroenterology/Urology 5.1.3. Legally Marketed Predicate Device The legally marketed predicate device is the Fresenius stay•safe Patient Connectors (K041792). This predicate has not been subject to a design-related recall. 5.1.4. Device Description 5.1.4.1. Device Identificat… | 2004 |
| * | K895991 | Peritoneal Dialysis Drainage Set NO. 48-0025-6Summary page 10…ication Panel: Gastroenterology/Urology 5.2.3. Legally Marketed Predicate Device The legally marketed predicate device is the Peritoneal Dialysis Drainage Set (K895991). 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 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 28, 2021 | Class II | Z-2089-2021 | Environmental control | Exposed to freezing temperatures due to refrigerated truck malfunctions |
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.
- K022412Fresenius Capd Stay.Safe Disposable Administration Sets with Stay.Safe ConnectorFresenius Medical Care North America · 2003 · 2 generations back · ◆ in the 2003 ancestors bar of FIG. 15 Class I recalls
What does this lineage say?
- The line of descent spans 37 years and passes through 3 companies; a new generation was cleared every 23.1 years on median.
- 1 of the 6 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. 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?
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…
Read the full statement (164 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173651 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173651: Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173651
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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