510(k) · Decided
DecidedArgyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender
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 Jul 27, 2018 as substantially equivalent to K071167 (Medigroup, Inc., 2007) after a 154-day review. Its family tree reaches back 2 generations to 1983.
- Decided
- Jul 27, 2018
- Review
- 154 days
- Class
- Class II
- Product code
- FJS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K823331 (1983). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K823331 | PC-204 Tunnelor | Medigroup | 1983 | — |
| −1 | K071167 | Flex-Neck Exxtended Peritoneal Dialysis Catheter and Accessories, Model CF-5560 | Medigroup, Inc. | 2007 | — |
| 0 (this device) | K180485 | Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal… | Covidien, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 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.
Planning a device in FJS? 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 FJS device
- #1 K213602 Argyle Peritoneal Dialysis Cathetor and Kit…score 3.0 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K071167 | Flex-Neck Exxtended Peritoneal Dialysis Catheter and Accessories, Model CF-5560Summary page 5…Page 2 of 5 5.3 Predicate Device Flex-Neck® ExxTended™ PD Catheter & Accessories, FJS, K071167 5.4 Device Description The Argyle™ Peritoneal Dialysis Catheter products are single lumen catheters for acute and chronic pe… | 2007 |
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 35 years and passes through 3 companies; a new generation was cleared every 24.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K071167.
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. 2018, 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 peritoneal catheter is indicated for acute and chronic peritoneal dialysis. The peritoneal dialysis catheter may be inserted using open, laparoscopic or percutaneous surgical techniques. The presternal peritoneal catheter is indicated for acute and chronic peritoneal dialysis. The Peritoneal Dialysis catheter may be inserted using open, laparoscopic or percutaneous surgical techniques. The Two Part Titanium Luer Adapter is indicated for acute and…
Read the full statement (154 words)
The peritoneal catheter is indicated for acute and chronic peritoneal dialysis.
The peritoneal dialysis catheter may be inserted using open, laparoscopic or percutaneous surgical techniques.
The presternal peritoneal catheter is indicated for acute and chronic peritoneal dialysis.
The Peritoneal Dialysis catheter may be inserted using open, laparoscopic or percutaneous surgical techniques.
The Two Part Titanium Luer Adapter is indicated for acute and chronic peritoneal dialysis, to be used with the Argyle(TM) Peritoneal Dialysis Catheter and the Argyle(TM) Presternal Peritoneal Dialysis Catheter.
The Two Part Titanium Luer Adapter is designed to provide a permanent threaded closure when used with a standard continuous ambulatory peritoneal dialysis (CAPD) transfer set.
The Titanium Catheter Extender is indicated for acute and chronic peritoneal dialysis, to be used with the Argyle(TM) Peritoneal Dialysis Catheter and the Argyle(TM) Presternal Peritoneal Dialysis Catheter.
The adult catheter extender is used to extend a catheter by connecting two portions of the peritoneal catheter tubing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180485 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180485: Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180485
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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