510(k) · Cleared
ClearedMedigroup Catheter Extender/Repair Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Janin Group, Inc. · FJS Catheter, Peritoneal, Long-Term Indwelling
Cleared on Feb 4, 2002 after a 185-day review. The FDA summary names its predicate without a number.
- Decided
- Feb 4, 2002
- Review
- 185 days
- Class
- Class II
- Product code
- FJS
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | Extender/Repair Kit marketed by Kendall, Quinton Named without a submission number |
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.
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.
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?
This device is intended for use with Flex-Neck™ catheters and Ash Advantage™ catheters in the event one of two situations described below should occur: 1. Extender Application In some patients, the external portion of the PD catheter may be too short for them to comfortably use. For example, obese patients may need an extender kit to be able to work with the external part of the catheter. Other patients may require the external end of the catheter to be…
Read the full statement (194 words)
This device is intended for use with Flex-Neck™ catheters and Ash Advantage™ catheters in the event one of two situations described below should occur:
1. Extender Application
In some patients, the external portion of the PD catheter may be too short for them to comfortably use. For example, obese patients may need an extender kit to be able to work with the external part of the catheter. Other patients may require the external end of the catheter to be more centrally located than it normally might be.
2. Repair Application
If a peritoneal dialysis catheter develops a fracture in the external portion, the catheter must be trimmed to eliminate the fracture. Doing so, by definition, will shorten the catheter and may make it impractical or difficult or even unsuitable for use. Rather than replace the entire catheter, it is desirable to retain the catheter by extending the external part of the catheter with new tubing.
In either situation, this device enables qualified medical staff to extend and/or repair the external part of an existing Flex-Neck catheter or Ash Advantage catheter by adding a 20 cm long tube to the existing and/or remaining catheter tubing.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012502 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012502: Medigroup Catheter Extender/Repair Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012502
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026