510(k) · Cleared
ClearedSupercath 5 Model SP120-XX-XX, SP125-XX-XX
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 Dec 17, 2009 as substantially equivalent to K013800 (Becton Dickinson Infusion Therapy Systems, Inc., 2001) and 1 other predicate after a 30-day review. Its family tree reaches back 3 generations to 1986. 27 later devices descend from it.
- Decided
- Dec 17, 2009
- Review
- 30 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K854773 (1986). 6 ancestors in all. 27 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK854773 Supercath a.V. FistulaTogo Medikit Co., Ltd. · 1986
- 2 generations backK050114 Supercath Z3VTogo Medikit Co., Ltd. · 2005
- 1 generation backK081953 Supercath 5Togo Medikit Co., Ltd. · 2009
- This deviceK093546 Supercath 5 Model SP120-XX-XX, SP125-XX-XXTogo Medikit Co., Ltd. · 2009
- Descendant · cites it directly · 21 of its ownK110443 BD Insyte Autoguard BCBecton, Dickinson & CO · 2011
- Descendant · 2 generations on · 7 of its ownK140504 Accucath BC Intravascular Catheter SystemVascular Pathways, Inc. · 2014
- Descendant · 3 generations on · 5 of its ownK153298 AccuCath Intravascular CatheterC.R. Bard, Inc. · 2015
- Descendant · 2 generations on · 4 of its ownK172506 BD Cathena Safety IV CatheterBecton, Dickinson and Company · 2017
- Descendant · 4 generations on · 4 of its ownK162894 AccuCath Intravascular CatheterC.R. Bard, Inc. · 2016
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K110443BD Insyte Autoguard BCBecton, Dickinson & CO · 2011 · cites it directly21descendants
- K140504Accucath BC Intravascular Catheter SystemVascular Pathways, Inc. · 2014 · 2 generations on7descendants
- K153298AccuCath Intravascular CatheterC.R. Bard, Inc. · 2015 · 3 generations on5descendants
- K172506BD Cathena Safety IV CatheterBecton, Dickinson and Company · 2017 · 2 generations on4descendants
- K162894AccuCath Intravascular CatheterC.R. Bard, Inc. · 2016 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K854773 | Supercath a.V. Fistula | Togo Medikit Co., Ltd. | 1986 | — |
| −2 | K050114 | Supercath Z3V | Togo Medikit Co., Ltd. | 2005 | — |
| −1 | K081953 | Supercath 5 | Togo Medikit Co., Ltd. | 2009 | — |
| 0 (this device) | K093546 | Supercath 5 Model SP120-XX-XX, SP125-XX-XX | Togo Medikit Co., Ltd. | 2009 | — |
| +1 | K110443 | BD Insyte Autoguard BC | Becton, Dickinson & CO | 2011 | — |
| +2 | K140504 | Accucath BC Intravascular Catheter System | Vascular Pathways, Inc. | 2014 | — |
| +3 | K153298 | AccuCath Intravascular Catheter | C.R. Bard, Inc. | 2015 | — |
| +2 | K172506 | BD Cathena Safety IV Catheter | Becton, Dickinson and Company | 2017 | — |
| +4 | K162894 | AccuCath Intravascular Catheter | C.R. Bard, Inc. | 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 |
|---|---|---|
| 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), 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 |
|---|---|---|---|
| * | K013800 | Insyte, Angiocath, Insyte Autoguard, Angiocath Autoguard, Autoguard Pro, Intima, and…Summary page 2…TIFICATION 5 10(k) e. Predicate devices The SUPERCATH 5 is substantially equivalent to the following legally marketed devices: 5 10(k): k013800 Trade name: Insyte Autoguardtm IV Catheter Product code: FOZ The same trade name wit… | 2001 |
| * | K081953 | Supercath 5Summary page 2…Insyte Autoguardtm IV Catheter Product code: FOZ The same trade name with the device for the application; 51 0(k): k081953 Trade name: SUPERCATH 5 Product code: FOZ f. Description of the device The device is… | 2009 |
What descends from it? (27)
See all 273 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 23 years and passes through 1 company; a new generation was cleared every 3.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K110443 (Becton, Dickinson & CO, 2011) has gone furthest, with 21 descendants of its own.
- 6 other devices also cite its predicate K013800.
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. 2009, 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/K093546 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093546: Supercath 5 Model SP120-XX-XX, SP125-XX-XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093546
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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