510(k) · Decided
DecidedFlex-Neck Exxtended Peritoneal Dialysis Catheter and Accessories, Model CF-5560
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medigroup, Inc. · FJS Catheter, Peritoneal, Long-Term Indwelling
Cleared on Aug 31, 2007 as substantially equivalent to K950042 (Accurate Surgical Instruments Co., 1995) and 2 other predicates after a 127-day review. Its family tree reaches back 1 generation to 1983. 2 later devices descend from it.
- Decided
- Aug 31, 2007
- Review
- 127 days
- Class
- Class II
- Product code
- FJS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K823331 (1983). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK823331 PC-204 TunnelorMedigroup · 1983
- This deviceK071167 Flex-Neck Exxtended Peritoneal Dialysis Catheter and Accessories…Medigroup, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK180485 Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal…Covidien, LLC · 2018
- Descendant · cites it directly · 0 of its ownK121383 PS X Series (Basic Components and Catheter), PD X Series (Catheter…Medical Components, Inc. · 2012
Most influential descendants
Showing 2 of 2 · See all- K180485Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis…Covidien, LLC · 2018 · cites it directly0descendants
- K121383PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components)Medical Components, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K823331 | PC-204 Tunnelor | Medigroup | 1983 | — |
| 0 (this device) | K071167 | Flex-Neck Exxtended Peritoneal Dialysis Catheter and Accessories, Model CF-5560 | Medigroup, Inc. | 2007 | — |
| +1 | K180485 | Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal… | Covidien, LLC | 2018 | — |
| +1 | K121383 | PS X Series (Basic Components and Catheter), PD X Series (Catheter with All… | Medical Components, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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.
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? (3)
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 |
|---|---|---|---|
| * | K950042 | Swan Neck Presternal Peritoneal Dialysis CatheterSummary page 1…Class: IL Predicate Devices 5 10(k) K950042 Swan-Neck"M Presternal PD Catheter issued Dec 15, 1995 510(k) K970159 Flex-Neck® PD Cathet… | 1995 |
| * | K970159 | Flex-Neck PD CatheterSummary page 1…icate Devices 5 10(k) K950042 Swan-Neck"M Presternal PD Catheter issued Dec 15, 1995 510(k) K970159 Flex-Neck® PD Catheter issued Sept 5, 1997 510(k) K823331 Tunnelor issued Jan 26, 1983… | 1997 |
| * | K823331 | PC-204 TunnelorSummary page 1…theter issued Dec 15, 1995 510(k) K970159 Flex-Neck® PD Catheter issued Sept 5, 1997 510(k) K823331 Tunnelor issued Jan 26, 1983 Product Description This de… | 1983 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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. 2007, 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?
If a patient is a suitable adult candidate for peritoneal dialysis (PD) therapy, the Flex-Neck® ExxTended TM peritoneal dialysis catheter can be implanted either surgically, laparoscopically, or peritoneoscopically for acute or chronic peritoneal dialysis. Stencils sold with the device, and marketed separately, will be used to assist the physician to locate the optimum primary implantation site and the optimum catheter exit site for the Flex-Neck® ExxTendedTM Catheter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071167 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071167: Flex-Neck Exxtended Peritoneal Dialysis Catheter and Accessories, Model CF-5560.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071167
Report an extraction error
Are you the manufacturer?
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