510(k) · Cleared
Recalled · Class I · 2024Fresenius Capd Stay.Safe Disposable Administration Sets with Stay.Safe Connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Medical Care North America · KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Cleared on Mar 5, 2003 after a 224-day review. The FDA summary names its predicate without a number. 1 of the 3 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled 5 times, including 5 Class I recalls.
- Decided
- Mar 5, 2003
- Review
- 224 days
- Class
- Class II
- Product code
- KDJ
- Recalls
- 5 (5 Class I)
- Predicates
- 0
2 later devices descend from it, 1 citing it directly. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- This deviceK022412 Fresenius Capd Stay.Safe Disposable Administration Sets with…Fresenius Medical Care North America · 2003
- Descendant · cites it directly · 1 of its ownK041792 Fresenius Staysafe Patient Connectors, Model 050-87211Fresenius Medical Care North America · 2004
- Descendant · 2 generations on · 0 of its ownK173651 Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe…Fresenius Medical Care Renal Therapies Group, LLC · 2018 · Recalled
Most influential descendants
Showing 2 of 2 · See all- K041792Fresenius Staysafe Patient Connectors, Model 050-87211Fresenius Medical Care North America · 2004 · cites it directly1descendant
- K173651Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain SetFresenius Medical Care Renal Therapies Group, LLC · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022412 | Fresenius Capd Stay.Safe Disposable Administration Sets with Stay.Safe Connector | Fresenius Medical Care North America | 2003 | — |
| +1 | K041792 | Fresenius Staysafe Patient Connectors, Model 050-87211 | Fresenius Medical Care North America | 2004 | — |
| +2 | K173651 | Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set | Fresenius Medical Care Renal Therapies Group, LLC | 2018 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | — | CAPD Safe-LockTMTransfer Sets with Pre-filled Connector Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041792 | Fresenius Staysafe Patient Connectors, Model 050-87211 | 2004 | 1 |
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?
- Of its descendants, K041792 (Fresenius Medical Care North America, 2004) has gone furthest, with 1 descendant 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.
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 Fresenius CAPD stayesafe@Disposable Administration Sets with stayesafe@Connector is indicated for use in end stage acute and chronic renal disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022412: Fresenius Capd Stay.Safe Disposable Administration Sets with Stay.Safe Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022412
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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