510(k) · Cleared

Cleared

Supercath Z3V

K050114510(k) TraditionalCleared Jun 9, 2005142-day reviewClass II21 CFR 880.5200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Togo Medikit Co., Ltd. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Cleared on Jun 9, 2005 as substantially equivalent to K030571 (Ethicon Endo-Surgery, Inc., 2003) and 2 other predicates after a 142-day review. Its family tree reaches back 1 generation to 1986. 30 later devices descend from it.

Decided: Jun 9, 2005
Review: 142 days
Class: Class II
Product code: FOZ
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K854773 (1986). 3 ancestors in all. 30 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK854773 Supercath a.V. FistulaTogo Medikit Co., Ltd. · 1986
This deviceK050114 Supercath Z3VTogo Medikit Co., Ltd. · 2005
Descendant · cites it directly · 28 of its ownK081953 Supercath 5Togo Medikit Co., Ltd. · 2009
Descendant · 2 generations on · 27 of its ownK093546 Supercath 5 Model SP120-XX-XX, SP125-XX-XXTogo Medikit Co., Ltd. · 2009
Descendant · 3 generations on · 21 of its ownK110443 BD Insyte Autoguard BCBecton, Dickinson & CO · 2011
Descendant · 4 generations on · 7 of its ownK140504 Accucath BC Intravascular Catheter SystemVascular Pathways, Inc. · 2014
Descendant · 5 generations on · 5 of its ownK153298 AccuCath Intravascular CatheterC.R. Bard, Inc. · 2015

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2006high 4 (2025) · low 0 (2007)2026

Most influential descendants

Showing 5 of 30 · See all

K081953Supercath 5Togo Medikit Co., Ltd. · 2009 · cites it directly28descendants
K093546Supercath 5 Model SP120-XX-XX, SP125-XX-XXTogo Medikit Co., Ltd. · 2009 · 2 generations on27descendants
K110443BD Insyte Autoguard BCBecton, Dickinson & CO · 2011 · 3 generations on21descendants
K140504Accucath BC Intravascular Catheter SystemVascular Pathways, Inc. · 2014 · 4 generations on7descendants
K153298AccuCath Intravascular CatheterC.R. Bard, Inc. · 2015 · 5 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K854773	Supercath a.V. Fistula	Togo Medikit Co., Ltd.	1986	—
0 (this device)	K050114	Supercath Z3V	Togo Medikit Co., Ltd.	2005	—
+1	K081953	Supercath 5	Togo Medikit Co., Ltd.	2009	—
+2	K093546	Supercath 5 Model SP120-XX-XX, SP125-XX-XX	Togo Medikit Co., Ltd.	2009	—
+3	K110443	BD Insyte Autoguard BC	Becton, Dickinson & CO	2011	—
+4	K140504	Accucath BC Intravascular Catheter System	Vascular Pathways, Inc.	2014	—
+5	K153298	AccuCath Intravascular Catheter	C.R. Bard, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0
2003	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
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

FIG. 1 — Lineage of K050114, 1986–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (3)

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	Applicant	Decided	Recalls
*	K030571	Acuvance Plus Safety IV Catheter, Protectiv Plus Safety IV Catheter, Optiva IV Catheter Summary page 1 …r Classification Name: Catheter, Intravascular (short-term) e. Predicate Devices: This device is substantially equivalent to "PROTECTIV PLUS Safety IV Catheter" (K030571) and Togo Medikit's Supercath IV (K864038) and Supercath AV (K854773). f. Description of the Device: The SUPERCATH Z3V intr…	Ethicon Endo-Surgery, Inc.	2003	—
*	K864038	Supercath I.V. Catheter Summary page 1 …scular (short-term) e. Predicate Devices: This device is substantially equivalent to "PROTECTIV PLUS Safety IV Catheter" (K030571) and Togo Medikit's Supercath IV (K864038) and Supercath AV (K854773). f. Description of the Device: The SUPERCATH Z3V intravascular catheter is intended to access v…	Togo Medikit Co., Ltd.	1986	—
*	K854773	Supercath a.V. Fistula Summary page 1 …edicate Devices: This device is substantially equivalent to "PROTECTIV PLUS Safety IV Catheter" (K030571) and Togo Medikit's Supercath IV (K864038) and Supercath AV (K854773). f. Description of the Device: The SUPERCATH Z3V intravascular catheter is intended to access vein or artery and to adm…	Togo Medikit Co., Ltd.	1986	—

Also cleared against K030571: 1 other device →

What descends from it? (30)

See all 30

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K081953	Supercath 5	Togo Medikit Co., Ltd.	2009	28
K112290	Supercath Z3V	Togo Medikit Co., Ltd.	2012	4
K052267	Supercath V	Togo Medikit Co., Ltd.	2006	0

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?

None of the 3 ancestors has a recall.
Of its descendants, K081953 (Togo Medikit Co., Ltd., 2009) has gone furthest, with 28 descendants of its own.
1 other device also cites its predicate K030571.

How does its category compare?

All FOZ devices

FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FOZ

11in 2025

2007high 13 (2012) · low 1 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FOZ

91in 2025

2007high 242 (2021) · low 28 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FOZ

4in 2023

2007high 115 (2010) · low 0 (2008)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · FOZ

5,110in 2025

2007high 5,110 (2025) · low 370 (2010)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 Z3V intravascular catheter is intended to access vein or artery and to administer fluids. The SUPERCATH Z3V is designed for short-term use (less than 30 days), is intended to minimize inadvertent needlesticks or is intended to reduce accidental needlesticks.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050114 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050114: Supercath Z3V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050114

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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