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 Mar 19, 2020 as substantially equivalent to K141070 (Togo Medikit Co., Ltd., 2015) after a 30-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Mar 19, 2020
- Review
- 30 days
- Class
- Class II
- Product code
- DRE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K954234 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
- 3 generations backK052557 Super Sheath Introducer SheathTogo Medikit Co., Ltd. · 2006 · Recalled
- 2 generations backK121504 Super Sheath Introducer Sheath and Super Sheath Introducer Sheath SetsTogo Medikit Co., Ltd. · 2012
- 1 generation backK141070 Super SheathTogo Medikit Co., Ltd. · 2015
- This deviceK200379 Super SheathTogo Medikit Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954234 | Radifocus Introducer II Kit | Terumo Medical Corp. | 1995 | — |
| −3 | K052557 | Super Sheath Introducer Sheath | Togo Medikit Co., Ltd. | 2006 | 1 |
| −2 | K121504 | Super Sheath Introducer Sheath and Super Sheath Introducer Sheath Sets | Togo Medikit Co., Ltd. | 2012 | — |
| −1 | K141070 | Super Sheath | Togo Medikit Co., Ltd. | 2015 | — |
| 0 (this device) | K200379 | Super Sheath | Togo Medikit Co., Ltd. | 2020 | — |
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? (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 | Decided |
|---|---|---|---|
| * | K141070 | Super SheathSummary page 5…Page 2 of 7 e. Predicate device Trade Name: Super Sheath 510(k) Number: K141070 Regulation Description: Vessel dilator for percutaneous catheterization Regulation Name: Dilator, Vessel, For percu… | 2015 |
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 25 years and passes through 2 companies; a new generation was cleared every 6.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
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. 2020, 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/K200379 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200379: Super Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200379
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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