510(k) · Cleared
ClearedSupercath a.V. Fistula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Togo Medikit Co., Ltd. · FIE Needle, Fistula
Cleared on Apr 8, 1986 after a 130-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 31 later devices descend from it.
- Decided
- Apr 8, 1986
- Review
- 130 days
- Class
- Class II
- Product code
- FIE
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 2 citing it directly.
- This deviceK854773 Supercath a.V. FistulaTogo Medikit Co., Ltd. · 1986
- Descendant · cites it directly · 30 of its ownK050114 Supercath Z3VTogo Medikit Co., Ltd. · 2005
- Descendant · 2 generations on · 28 of its ownK081953 Supercath 5Togo Medikit Co., Ltd. · 2009
- Descendant · 3 generations on · 27 of its ownK093546 Supercath 5 Model SP120-XX-XX, SP125-XX-XXTogo Medikit Co., Ltd. · 2009
- Descendant · 4 generations on · 21 of its ownK110443 BD Insyte Autoguard BCBecton, Dickinson & CO · 2011
- Descendant · 5 generations on · 7 of its ownK140504 Accucath BC Intravascular Catheter SystemVascular Pathways, Inc. · 2014
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K050114Supercath Z3VTogo Medikit Co., Ltd. · 2005 · cites it directly30descendants
- K081953Supercath 5Togo Medikit Co., Ltd. · 2009 · 2 generations on28descendants
- K093546Supercath 5 Model SP120-XX-XX, SP125-XX-XXTogo Medikit Co., Ltd. · 2009 · 3 generations on27descendants
- K110443BD Insyte Autoguard BCBecton, Dickinson & CO · 2011 · 4 generations on21descendants
- K140504Accucath BC Intravascular Catheter SystemVascular Pathways, Inc. · 2014 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K854773 | Supercath a.V. Fistula | Togo Medikit Co., Ltd. | 1986 | — |
| +1 | K050114 | Supercath Z3V | Togo Medikit Co., Ltd. | 2005 | — |
| +2 | K081953 | Supercath 5 | Togo Medikit Co., Ltd. | 2009 | — |
| +3 | K093546 | Supercath 5 Model SP120-XX-XX, SP125-XX-XX | Togo Medikit Co., Ltd. | 2009 | — |
| +4 | K110443 | BD Insyte Autoguard BC | Becton, Dickinson & CO | 2011 | — |
| +5 | K140504 | Accucath BC Intravascular Catheter System | Vascular Pathways, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FIE? 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 FIE device
- #1 K253469 Ritus™ Safety Fistula Cannula with Anti-Reflux…score 13.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (31)
See all 312 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?
- Of its descendants, K050114 (Togo Medikit Co., Ltd., 2005) has gone furthest, with 30 descendants of its own.
How does its category compare?
All FIE devicesFIE Needle, Fistula: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FIE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FIE
91in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FIE
3in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FIE
33in 2025
MAUDE reports naming product code FIE, 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 | 3 | 90 | 0 | 13 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 1 | — | 0 | 27 |
| 2010 | 3 | 29 | 0 | 17 |
| 2011 | 3 | 91 | 0 | 2 |
| 2012 | 1 | — | 3 | 7 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 2 | — | 0 | 4 |
| 2015 | 2 | — | 0 | 23 |
| 2016 | 0 | — | 0 | 21 |
| 2017 | 1 | — | 0 | 14 |
| 2018 | 1 | — | 0 | 16 |
| 2019 | 0 | — | 0 | 21 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 58 |
| 2024 | 0 | — | 0 | 14 |
| 2025 | 1 | — | 0 | 33 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K854773 · printed Nov 6, 2026
Cite this page
510(k) Report. “K854773: Supercath a.V. Fistula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K854773
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026