510(k) · Cleared
ClearedSupercath 5
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 Sep 20, 2019 as substantially equivalent to K140419 (Togo Medikit Co., Ltd., 2014) and 1 other predicate after a 261-day review. Its family tree reaches back 7 generations to 1986.
- Decided
- Sep 20, 2019
- Review
- 261 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K854773 (1986). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK854773 Supercath a.V. FistulaTogo Medikit Co., Ltd. · 1986
- 6 generations backK050114 Supercath Z3VTogo Medikit Co., Ltd. · 2005
- 5 generations backK081953 Supercath 5Togo Medikit Co., Ltd. · 2009
- 4 generations backK093546 Supercath 5 Model SP120-XX-XX, SP125-XX-XXTogo Medikit Co., Ltd. · 2009
- 3 generations backK112290 Supercath Z3VTogo Medikit Co., Ltd. · 2012
- 2 generations backK140419 SUPERCATH5Togo Medikit Co., Ltd. · 2014
- 1 generation backK172496 Supercath 5 (26G)Togo Medikit Co., Ltd. · 2018
- This deviceK190001 Supercath 5Togo Medikit Co., Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K854773 | Supercath a.V. Fistula | Togo Medikit Co., Ltd. | 1986 | — |
| −6 | K050114 | Supercath Z3V | Togo Medikit Co., Ltd. | 2005 | — |
| −5 | K081953 | Supercath 5 | Togo Medikit Co., Ltd. | 2009 | — |
| −4 | K093546 | Supercath 5 Model SP120-XX-XX, SP125-XX-XX | Togo Medikit Co., Ltd. | 2009 | — |
| −3 | K112290 | Supercath Z3V | Togo Medikit Co., Ltd. | 2012 | — |
| −2 | K140419 | SUPERCATH5 | Togo Medikit Co., Ltd. | 2014 | — |
| −1 | K172496 | Supercath 5 (26G) | Togo Medikit Co., Ltd. | 2018 | — |
| 0 (this device) | K190001 | Supercath 5 | Togo Medikit Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K140419 | SUPERCATH5Summary page 5…h 5 (Proposed) includes. Predicate Device for gauges 14G, 16G, 18G, 20G, 22G, and 24G Trade Name: Supercath 5 510(k) Number: K140419 Common Name: Catheter, Intravascular, Therapeutic, Short-term less than 30… | 2014 |
| * | K172496 | Supercath 5 (26G)Summary page 5…s submission. This predicate device is primary predicate. Predicate Device for 26G Trade Name: Supercath 5 510(k) Number: K172496 Common Name: Catheter, Intravascular, Therapeutic, Short-term less than 30… | 2018 |
| † | K160592 | Supercath 6 | 2016 |
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.
What does this lineage say?
- The line of descent spans 33 years and passes through 1 company; a new generation was cleared every 2.3 years on median.
- None of the 10 ancestors has a recall.
- 2 other devices also cite its predicate K140419.
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. 2019, 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 and/or blood. The Supercath 5 is designed for single use, and is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks. The 18 - 22 gauge catheters may be used with power injectors at a maximum pressure of 300 psi.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190001 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190001: Supercath 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190001
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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