510(k) · Cleared
ClearedSuper Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Togo Medikit Co., Ltd. · DRE Dilator, Vessel, For Percutaneous Catheterization
Cleared on Jan 15, 2015 as substantially equivalent to K052557 (Togo Medikit Co., Ltd., 2006) and 1 other predicate after a 265-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- Jan 15, 2015
- Review
- 265 days
- Class
- Class II
- Product code
- DRE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K954234 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
- 2 generations backK052557 Super Sheath Introducer SheathTogo Medikit Co., Ltd. · 2006 · Recalled
- 1 generation backK121504 Super Sheath Introducer Sheath and Super Sheath Introducer Sheath SetsTogo Medikit Co., Ltd. · 2012
- This deviceK141070 Super SheathTogo Medikit Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK200379 Super SheathTogo Medikit Co., Ltd. · 2020
Most influential descendants
Showing 1 of 1 · See all- K200379Super SheathTogo Medikit Co., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954234 | Radifocus Introducer II Kit | Terumo Medical Corp. | 1995 | — |
| −2 | K052557 | Super Sheath Introducer Sheath | Togo Medikit Co., Ltd. | 2006 | 1 |
| −1 | K121504 | Super Sheath Introducer Sheath and Super Sheath Introducer Sheath Sets | Togo Medikit Co., Ltd. | 2012 | — |
| 0 (this device) | K141070 | Super Sheath | Togo Medikit Co., Ltd. | 2015 | — |
| +1 | K200379 | Super Sheath | Togo Medikit Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 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
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 |
|---|---|---|---|
| * | K052557 | Super Sheath Introducer SheathSummary page 5…K141070, 510k Summary e. Predicate devices The SUPER SHEATH is substantially equivalent to the following legally marketed devices: 510(k): k052557 Trade name: Super Sheath Introducer Sheath and Introducer Sheath Sets, 4F-9F Regulation Number: 21 CFR 8… | 2006 |
| * | K121504 | Super Sheath Introducer Sheath and Super Sheath Introducer Sheath SetsSummary page 5…Super Sheath Introducer Sheath and Introducer Sheath Sets, 4F-9F Regulation Number: 21 CFR 870.1310 Product code: DRE 510(k): k121504 Trade name: Super Sheath Introducer Sheath and Introducer Sheath Sets, 3.3F Regulation Number: 21 CFR 87… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200379 | Super Sheath | 2020 | 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?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 6.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K200379 (Togo Medikit Co., Ltd., 2020) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K052557.
How does its category compare?
All DRE devicesDRE Dilator, Vessel, For Percutaneous Catheterization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DRE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRE
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRE
1in 2016
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DRE
356in 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?
The device is indicated for use in the introduction of diagnostic and interventional devices inserted into the peripheral and coronary vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141070 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141070: Super Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141070
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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