510(k) · Cleared
Recalled · Class II · 2023Fresenius Sterile Stay Safe Cap
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 Dec 29, 2008 as substantially equivalent to K921818 (Abbott Laboratories, 1994) after a 31-day review. Its family tree reaches back 1 generation to 1994. It has been recalled 2 times.
- Decided
- Dec 29, 2008
- Review
- 31 days
- Class
- Class II
- Product code
- KDJ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K921818 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK921818 Abbott Smart CapAbbott Laboratories · 1994
- This deviceK083542 Fresenius Sterile Stay Safe CapFresenius Medical Care North America · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921818 | Abbott Smart Cap | Abbott Laboratories | 1994 | — |
| 0 (this device) | K083542 | Fresenius Sterile Stay Safe Cap | Fresenius Medical Care North America | 2008 | — |
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.
Planning a device in KDJ? 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 |
|---|---|---|---|
| * | K921818 | Abbott Smart CapSummary page 2…rile Stay Safe® Cap is a modified version of the Fresenius Stay Safe Cap was cleared under the following premarket notifications: Fresenius Stay Safe®Cap · #K921818 (3/28/94); D. Indications for Usellntended Use: The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe® Cap… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2023 | Class II | Z-0507-2024 | Labeling design | Updating the labeling to include additional warnings and contraindications for potential side effects. |
| Apr 28, 2021 | Class II | Z-2090-2021 | Environmental control | Exposed to freezing temperatures due to refrigerated truck malfunctions |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no 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. 2008, 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 Fresenius Sterile Stay Safe® Cap is intended to be used for closure of the stay safe peritoneal dialysis connectology system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083542 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083542: Fresenius Sterile Stay Safe Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083542
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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