510(k) · Cleared
ClearedMedigroup Key Tube
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 Dec 6, 2001 after a 90-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).
- Decided
- Dec 6, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- FJS
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K883303 | FDA’s K883303 is Mentor Rapid-Span (TM) Tissue Expander Our OCR of the scanned summary read K883303, FDA’s number for Mentor Rapid-Span (TM) Tissue Expander (Mentor Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Cuff Implantor®”. Kept off the family tree. Summary page 1…an adaptation (not replacement) for an existing tool, Cuff Implantor®, currently produced by Medigroup and included in two of its Y- TEC® kits, VP-112 and VP-210, 510(k)883303A and adapted in April 7, 1993 letter to FDA. An early prototype Key Tube version was designed and used during the Ash Advantage™… | 1988 |
| † | K991042 | Ash Advantage Peritoneal Catheter | 1999 |
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?
The Key Tube is designed to be used to implant the Ash Advantage™ catheter. No usage change from original Ash Advantage catheter 510(k) 991042.
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/K013017 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013017: Medigroup Key Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013017
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026