510(k) · Cleared
ClearedDextrolyte II Peritoneal Dialysis 48-3029-7 Clamp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
National Medical Care, Medical Products Div., Inc. · FJH Dialyzer, Disposable
Cleared on Sep 21, 1992 after a 220-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 3 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Sep 21, 1992
- Review
- 220 days
- Class
- Class II
- Product code
- FJH
- Recalls
- None
- 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 deviceK920697 Dextrolyte II Peritoneal Dialysis 48-3029-7 ClampNational Medical Care, Medical Products Div., Inc. · 1992
- Descendant · cites it directly · 1 of its ownK173593 stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe…Fresenius Medical Care Renal Therapies Group, LLC · 2018 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK250404 stay•safe® catheter extension set with Safe- Lock, 12 inch…Fresenius Medical Care Renal Therapies Group, LLC · 2025
Class I recalls in this family
- K173593 stay•safe catheter extension set with Safe-Lock…cites it directly · 2018
Most influential descendants
Showing 2 of 2 · See all- K173593stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension…Fresenius Medical Care Renal Therapies Group, LLC · 2018 · cites it directly1descendant
- K250404stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter…Fresenius Medical Care Renal Therapies Group, LLC · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K920697 | Dextrolyte II Peritoneal Dialysis 48-3029-7 Clamp | National Medical Care, Medical Products Div., Inc. | 1992 | — |
| +1 | K173593 | stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter… | Fresenius Medical Care Renal Therapies Group, LLC | 2018 | Class I |
| +2 | K250404 | stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe®… | Fresenius Medical Care Renal Therapies Group, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 1 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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 |
|---|---|---|---|
| K173593 | stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension… Class I | 2018 | 1 |
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.
- K173593stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6…Fresenius Medical Care Renal Therapies Group, LLC · 2018 · Cites it directly · ◆ in the 2018 descendants bar of FIG. 15 Class I recalls
What does this lineage say?
- Of its descendants, K173593 (Fresenius Medical Care Renal Therapies Group, LLC, 2018) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FJH devicesFJH Dialyzer, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FJH
FDA has decided no FJH device since 2007.
Median 510(k) review, days · FJH
Too few FJH 510(k)s in any year since 2007 to give a median.
Recalls per year · FJH
No recall names FJH since 2007.
Adverse event reports per year · FJH
No MAUDE report names FJH since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K920697 · printed Nov 6, 2026
Cite this page
510(k) Report. “K920697: Dextrolyte II Peritoneal Dialysis 48-3029-7 Clamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920697
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026