510(k) · Cleared
ClearedArgyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC · FJS Catheter, Peritoneal, Long-Term Indwelling
Cleared on Jan 14, 2022 as substantially equivalent to K060897 (Medigroup, Inc., 2006) after a 60-day review. Its family tree reaches back 2 generations to 1983.
- Decided
- Jan 14, 2022
- Review
- 60 days
- Class
- Class II
- Product code
- FJS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K823331 (1983). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 FJS? 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? (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 |
|---|---|---|---|
| * | K060897 | Embedding Tool, Model TE-1000Summary page 4…on Number: 21 CFR 876.5630 Product Code: FJS Classification: Class II 5.3 Predicate Device Embedding® Tool, FJS, K060897 5.4 Device Description The Ritus™ tunneling tool kit comes with a separate tunneling device and plug. This kit is designed t… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 39 years and passes through 3 companies; a new generation was cleared every 23.5 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All FJS devicesFJS Catheter, Peritoneal, Long-Term Indwelling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · FJS
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · FJS
120in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FJS
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FJS
140in 2025
MAUDE reports naming product code FJS, 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 | 2 | — | 0 | 12 |
| 2008 | 0 | — | 0 | 9 |
| 2009 | 0 | — | 0 | 75 |
| 2010 | 0 | — | 0 | 67 |
| 2011 | 0 | — | 4 | 58 |
| 2012 | 3 | 120 | 0 | 37 |
| 2013 | 1 | — | 0 | 84 |
| 2014 | 0 | — | 1 | 66 |
| 2015 | 0 | — | 0 | 61 |
| 2016 | 0 | — | 0 | 38 |
| 2017 | 0 | — | 0 | 75 |
| 2018 | 1 | — | 0 | 137 |
| 2019 | 0 | — | 0 | 53 |
| 2020 | 0 | — | 0 | 94 |
| 2021 | 0 | — | 0 | 78 |
| 2022 | 1 | — | 0 | 102 |
| 2023 | 0 | — | 0 | 619 |
| 2024 | 0 | — | 0 | 149 |
| 2025 | 0 | — | 0 | 140 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Ritus™ tunneling tool kit is used to both create a tunnel tract through subcutaneous tissue and seal the end of the catheter. This allows the external portion of the Covidien™ peritoneal dialysis catheter to be temporarily buried in advance of dialysis for patients that are candidates for delayed peritoneal dialysis treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213602 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213602: Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213602
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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