510(k) · Cleared
ClearedFresenius Staysafe Patient Connectors, Model 050-87211
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 Sep 24, 2004 as substantially equivalent to K811986 (American Medical Products, Inc., 1981) and 3 other predicates after an 84-day review. Its family tree reaches back 1 generation to 1981. 1 of the 6 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Sep 24, 2004
- Review
- 84 days
- Class
- Class II
- Product code
- KDJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K811986 (1981). 4 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK811986 The Amp 80/2 Pediatric Cycler SystemAmerican Medical Products, Inc. · 1981
- This deviceK041792 Fresenius Staysafe Patient Connectors, Model 050-87211Fresenius Medical Care North America · 2004
- Descendant · cites it directly · 0 of its ownK173651 Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe…Fresenius Medical Care Renal Therapies Group, LLC · 2018 · Recalled
Class I recalls in this family
- K022412 Fresenius Capd Stay.Safe Disposable…direct predicate · 2003
Most influential descendants
Showing 1 of 1 · See all- K173651Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain SetFresenius Medical Care Renal Therapies Group, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K811986 | The Amp 80/2 Pediatric Cycler System | American Medical Products, Inc. | 1981 | — |
| 0 (this device) | K041792 | Fresenius Staysafe Patient Connectors, Model 050-87211 | Fresenius Medical Care North America | 2004 | — |
| +1 | K173651 | Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set | Fresenius Medical Care Renal Therapies Group, LLC | 2018 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 2003 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K811986 | The Amp 80/2 Pediatric Cycler SystemSummary page 1…now Marketed under ECOTM Peritoneal Dialysis 4 Lead Prefilled Set with Snap Disconnect) (#K8 11986 - SE 08/31/81); Fresenius CAPD StaySafe Disposabl… | 1981 |
| * | K022412 | Fresenius Capd Stay.Safe Disposable Administration Sets with Stay.Safe ConnectorSummary page 1…/31/81); Fresenius CAPD StaySafe Disposable Administration Sets with StaySafe Connector (#K022412 - SE 03/05/03); Fresenius AMP 80/2 Pediatric Cycl… | 2003 |
| * | K904806 | Capd Safelock Transfer Set W/Pre-Filled ConnectorSummary page 1…t with Snap Disconnect) (#K81 1986 - SE 08/31/81); Fresenius CAPD Safelock Transfer Set (#K904806 - SE 01/1 1/91); Closed Disconnect System (#K9001… | 1991 |
| * | K900106 | Closed Disconnect SystemSummary page 1…resenius CAPD Safelock Transfer Set (#K904806 - SE 01/1 1/91); Closed Disconnect System (#K900106 SE - 07/16/90); submitted under Delmed, now owned by Fresenius… | 1990 |
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 |
|---|---|---|---|
| K173651 | Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set | 2018 | 0 |
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.
- K022412Fresenius Capd Stay.Safe Disposable Administration Sets with Stay.Safe ConnectorFresenius Medical Care North America · 2003 · Direct predicate · ◆ in the 2003 ancestors bar of FIG. 15 Class I recalls
What does this lineage say?
- 1 of the 4 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K173651 (Fresenius Medical Care Renal Therapies Group, LLC, 2018) 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.
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 StaySafe Patient Connectors are intended for use with a peritoneal cycler for drainage and infusion of PD solution during a peritoneal dialysis exchanges. The Fresenius StaySafe Patient Connectors are indicated for use in acute and chronic peritoneal dialysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041792 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041792: Fresenius Staysafe Patient Connectors, Model 050-87211.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041792
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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