510(k) · Cleared

Recalled · 2011

Super Sheath Introducer Sheath

K052557510(k) TraditionalCleared Jan 17, 2006123-day reviewClass II21 CFR 870.1310Recalls 1

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. · DRE Dilator, Vessel, For Percutaneous Catheterization

Cleared on Jan 17, 2006 as substantially equivalent to K954234 (Terumo Medical Corp., 1995) after a 123-day review. Its family tree reaches back 1 generation to 1995. 30 later devices descend from it. It has been recalled once.

Decided: Jan 17, 2006
Review: 123 days
Class: Class II
Product code: DRE
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K954234 (1995). 30 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
This deviceK052557 Super Sheath Introducer SheathTogo Medikit Co., Ltd. · 2006
Descendant · cites it directly · 13 of its ownK060190 Super Sheath XL Introducer SheathTogo Medikit Co., Ltd. · 2006
Descendant · 2 generations on · 12 of its ownK091006 Itg Vascular Access System, Model 300Arstasis, Inc. · 2010 · Recalled
Descendant · 3 generations on · 11 of its ownK100615 Arstasis Access SystemArstasis, Inc. · 2010 · Recalled
Descendant · 4 generations on · 10 of its ownK102728 Arstasis Access SystemArstasis, Inc. · 2010 · Recalled
Descendant · cites it directly · 9 of its ownK121504 Super Sheath Introducer Sheath and Super Sheath Introducer Sheath SetsTogo Medikit Co., Ltd. · 2012

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2006high 4 (2013) · low 0 (2008)2026

Most influential descendants

Showing 5 of 30 · See all

K060190Super Sheath XL Introducer SheathTogo Medikit Co., Ltd. · 2006 · cites it directly13descendants
K091006Itg Vascular Access System, Model 300Arstasis, Inc. · 2010 · 2 generations on12descendants
K100615Arstasis Access SystemArstasis, Inc. · 2010 · 3 generations on11descendants
K102728Arstasis Access SystemArstasis, Inc. · 2010 · 4 generations on10descendants
K121504Super Sheath Introducer Sheath and Super Sheath Introducer Sheath SetsTogo Medikit Co., Ltd. · 2012 · cites it directly9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K954234	Radifocus Introducer II Kit	Terumo Medical Corp.	1995	—
0 (this device)	K052557	Super Sheath Introducer Sheath	Togo Medikit Co., Ltd.	2006	—
+1	K060190	Super Sheath XL Introducer Sheath	Togo Medikit Co., Ltd.	2006	—
+2	K091006	Itg Vascular Access System, Model 300	Arstasis, Inc.	2010	1
+3	K100615	Arstasis Access System	Arstasis, Inc.	2010	1
+4	K102728	Arstasis Access System	Arstasis, Inc.	2010	1
+1	K121504	Super Sheath Introducer Sheath and Super Sheath Introducer Sheath Sets	Togo Medikit Co., Ltd.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	0
2010	3	0
2011	2	0
2012	2	0
2013	4	0
2014	3	0
2015	3	0
2016	2	0
2017	3	0
2018	1	0
2019	1	0
2020	1	0
2024	1	0
2026	2	0

FIG. 1 — Lineage of K052557, 1995–2026Source: 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 DRE? 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 DRE device

#1 K261310 FlexTract Deflectable-Rotational Dilator…score 12.0 · 2 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? (1)

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
*	K954234	Radifocus Introducer II Kit Summary page 1 …Class 11, 21 CFR Part 870.1340 Predicate Device Terumno Pinnacle Introducer Sheaths K954234 November 27, 1995 Togo Medikit Co. LTD. Introducer Sheaths and Introducer Sheath Sets…	Terumo Medical Corp.	1995	—

Also cleared against K954234: 4 other devices →

What descends from it? (30)

See all 30

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

Number	Device	Applicant	Decided	Descendants
K060190	Super Sheath XL Introducer Sheath	Togo Medikit Co., Ltd.	2006	13
K121504	Super Sheath Introducer Sheath and Super Sheath Introducer Sheath Sets	Togo Medikit Co., Ltd.	2012	9
K141275	Endophys Pressure Sensing Sheath Kit	Endophys, Inc.	2015	4
K141070	Super Sheath	Togo Medikit Co., Ltd.	2015	1
K062554	Starclose Hex-Hub Dilator	Abbott Vascular, Inc.	2007	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 3, 2011	Not classified	Z-0264-2012	Packaging process control	Boston Scientific is initiating a medical device recall removal regarding nine lots/batches of Super Sheath and Super Sheath R/O Introducer Sheaths. Boston Scientific was informed through product complaints that the 0.035" ID dilator may…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K060190 (Togo Medikit Co., Ltd., 2006) has gone furthest, with 13 descendants of its own.
4 other devices also cite its predicate K954234.

How does its category compare?

All DRE devices

DRE Dilator, Vessel, For Percutaneous Catheterization: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRE

3in 2025

2007high 6 (2014) · low 1 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRE

31in 2025

2007high 261 (2022) · low 30 (2015)2026

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

Recalls per year · DRE

1in 2016

2007high 2 (2009) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · DRE

356in 2025

2007high 386 (2023) · low 38 (2008)2025

MAUDE reports naming product code DRE, 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	5	160	0	81
2008	2	—	0	38
2009	2	—	2	69
2010	1	—	2	73
2011	1	—	1	90
2012	1	—	0	132
2013	4	111	0	120
2014	6	72	0	82
2015	4	30	1	82
2016	3	90	1	84
2017	4	108	0	101
2018	2	—	0	126
2019	3	68	0	144
2020	3	30	0	120
2021	1	—	0	115
2022	3	261	0	136
2023	2	—	0	386
2024	1	—	0	325
2025	3	31	0	356
2026	1	—	1 (1)	—

What is it indicated for?

Introducer Sheaths and Introducer Sheath Sets are intended for use in the introduction of diagnostic and interventional devices into the human vasculature.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052557 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052557: Super Sheath Introducer Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052557

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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