510(k) · Cleared
ClearedSUPERCATH5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Togo Medikit Co., Ltd. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on May 12, 2014 as substantially equivalent to K093546 (Togo Medikit Co., Ltd., 2009) and 1 other predicate after an 83-day review. Its family tree reaches back 5 generations to 1986. 3 later devices descend from it.
- Decided
- May 12, 2014
- Review
- 83 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K854773 (1986). 8 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK854773 Supercath a.V. FistulaTogo Medikit Co., Ltd. · 1986
- 4 generations backK050114 Supercath Z3VTogo Medikit Co., Ltd. · 2005
- 3 generations backK081953 Supercath 5Togo Medikit Co., Ltd. · 2009
- 2 generations backK093546 Supercath 5 Model SP120-XX-XX, SP125-XX-XXTogo Medikit Co., Ltd. · 2009
- 1 generation backK112290 Supercath Z3VTogo Medikit Co., Ltd. · 2012
- This deviceK140419 SUPERCATH5Togo Medikit Co., Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK172496 Supercath 5 (26G)Togo Medikit Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK190001 Supercath 5Togo Medikit Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK160592 Supercath 6Togo Medikit Co., Ltd. · 2016
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K854773 | Supercath a.V. Fistula | Togo Medikit Co., Ltd. | 1986 | — |
| −4 | K050114 | Supercath Z3V | Togo Medikit Co., Ltd. | 2005 | — |
| −3 | K081953 | Supercath 5 | Togo Medikit Co., Ltd. | 2009 | — |
| −2 | K093546 | Supercath 5 Model SP120-XX-XX, SP125-XX-XX | Togo Medikit Co., Ltd. | 2009 | — |
| −1 | K112290 | Supercath Z3V | Togo Medikit Co., Ltd. | 2012 | — |
| 0 (this device) | K140419 | SUPERCATH5 | Togo Medikit Co., Ltd. | 2014 | — |
| +1 | K172496 | Supercath 5 (26G) | Togo Medikit Co., Ltd. | 2018 | — |
| +1 | K190001 | Supercath 5 | Togo Medikit Co., Ltd. | 2019 | — |
| +1 | K160592 | Supercath 6 | Togo Medikit Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 FOZ? 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 FOZ device
- #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K093546 | Supercath 5 Model SP120-XX-XX, SP125-XX-XXSummary page 2…FACSIMU e. Predicate devices The SUPERCATH 5 is substantially equivalent to the following legally marketed devices: 5 10(k): k093546 Trade name: SUPERCATH 5 Product code: FOZ 5 10(k): kU12290 Trade name:… | 2009 |
| * | K112290 | Supercath Z3VSummary page 5…predicate devices, TOGO MEDIKIT concludes that the SUPERCATH 5 (PROPOSED) is substantially equivalent to the the SUPERCATH 5 (k093546) and the SUPERCATH Z3V (k112290) , and the SUPERCATH 5 (PROPOSED) does not raise any new questions regarding safety or effectiveness. SUPERCATH 5… | 2012 |
What descends from it? (3)
3 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?
- The line of descent spans 28 years and passes through 1 company; a new generation was cleared every 2.3 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K172496 (Togo Medikit Co., Ltd., 2018) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K093546.
How does its category compare?
All FOZ devicesFOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FOZ
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FOZ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FOZ
4in 2023
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · FOZ
5,110in 2025
MAUDE reports naming product code FOZ, 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 | 6 | 159 | 16 | 374 |
| 2008 | 9 | 103 | 0 | 422 |
| 2009 | 9 | 30 | 23 | 508 |
| 2010 | 3 | 28 | 115 | 370 |
| 2011 | 6 | 132 | 0 | 786 |
| 2012 | 13 | 122 | 0 | 560 |
| 2013 | 4 | 104 | 2 | 640 |
| 2014 | 9 | 99 | 4 | 815 |
| 2015 | 10 | 107 | 0 | 729 |
| 2016 | 9 | 63 | 3 (1) | 925 |
| 2017 | 9 | 51 | 22 | 1,966 |
| 2018 | 1 | — | 4 | 3,305 |
| 2019 | 8 | 140 | 3 | 4,365 |
| 2020 | 10 | 191 | 3 | 3,797 |
| 2021 | 4 | 242 | 1 | 4,674 |
| 2022 | 8 | 183 | 4 (2) | 4,133 |
| 2023 | 9 | 129 | 4 (2) | 4,430 |
| 2024 | 6 | 190 | 0 | 4,772 |
| 2025 | 11 | 91 | 0 | 5,110 |
| 2026 | 7 | 203 | 2 | — |
What is it indicated for?
The SUPERCATH 5 is intended to access a vein or artery and to administer fluids. The SUPERCATH 5 is designed for single use and for short-term use (less than 30 days), is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140419 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140419: SUPERCATH5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140419
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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