510(k) · Cleared
ClearedSuper Sheath XL Introducer Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Togo Medikit Co., Ltd. · DYB Introducer, Catheter
Cleared on Apr 4, 2006 as substantially equivalent to K052557 (Togo Medikit Co., Ltd., 2006) after a 70-day review. Its family tree reaches back 2 generations to 1995. 13 later devices descend from it.
- Decided
- Apr 4, 2006
- Review
- 70 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K954234 (1995). 13 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
- 1 generation backK052557 Super Sheath Introducer SheathTogo Medikit Co., Ltd. · 2006 · Recalled
- This deviceK060190 Super Sheath XL Introducer SheathTogo Medikit Co., Ltd. · 2006
- Descendant · cites it directly · 12 of its ownK091006 Itg Vascular Access System, Model 300Arstasis, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 11 of its ownK100615 Arstasis Access SystemArstasis, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 10 of its ownK102728 Arstasis Access SystemArstasis, Inc. · 2010 · Recalled
- Descendant · 4 generations on · 9 of its ownK103143 Arstasis One Latchwire Access SystemArstasis, Inc. · 2011
- Descendant · 5 generations on · 8 of its ownK113110 Axera Access SystemArstasis, Inc. · 2011
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K091006Itg Vascular Access System, Model 300Arstasis, Inc. · 2010 · cites it directly12descendants
- K100615Arstasis Access SystemArstasis, Inc. · 2010 · 2 generations on11descendants
- K102728Arstasis Access SystemArstasis, Inc. · 2010 · 3 generations on10descendants
- K103143Arstasis One Latchwire Access SystemArstasis, Inc. · 2011 · 4 generations on9descendants
- K113110Axera Access SystemArstasis, Inc. · 2011 · 5 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954234 | Radifocus Introducer II Kit | Terumo Medical Corp. | 1995 | — |
| −1 | K052557 | Super Sheath Introducer Sheath | Togo Medikit Co., Ltd. | 2006 | 1 |
| 0 (this device) | K060190 | Super Sheath XL Introducer Sheath | Togo Medikit Co., Ltd. | 2006 | — |
| +1 | K091006 | Itg Vascular Access System, Model 300 | Arstasis, Inc. | 2010 | 1 |
| +2 | K100615 | Arstasis Access System | Arstasis, Inc. | 2010 | 1 |
| +3 | K102728 | Arstasis Access System | Arstasis, Inc. | 2010 | 1 |
| +4 | K103143 | Arstasis One Latchwire Access System | Arstasis, Inc. | 2011 | — |
| +5 | K113110 | Axera Access System | Arstasis, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 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 DYB? 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 DYB device
- #1 K251051 AuST Steerable Sheathscore 18.0 · 10 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 |
|---|---|---|---|
| * | K052557 | Super Sheath Introducer SheathSummary page 2…he Super Sheath Introducer XL Sheath Set consists of a sheath, a dilator and a mini guidewire, with inserter. The mini guidewires with inserter were cleared to market in K052557 (January 17, 2006). The construction of the sheath shaft and hub allows smooth passage of medical devices. The sheath shaft and h… | 2006 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091006 | Itg Vascular Access System, Model 300 | 2010 | 12 |
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 11 years and passes through 2 companies; a new generation was cleared every 10.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K091006 (Arstasis, Inc., 2010) has gone furthest, with 12 descendants of its own.
- 4 other devices also cite its predicate K052557.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DYB
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 2025
MAUDE reports naming product code DYB, 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 | 12 | 95 | 15 | 316 |
| 2008 | 17 | 37 | 9 | 423 |
| 2009 | 14 | 52 | 25 | 399 |
| 2010 | 18 | 123 | 18 | 445 |
| 2011 | 17 | 100 | 4 | 628 |
| 2012 | 22 | 128 | 3 | 898 |
| 2013 | 26 | 118 | 5 (1) | 743 |
| 2014 | 30 | 122 | 2 | 780 |
| 2015 | 17 | 129 | 2 (1) | 913 |
| 2016 | 19 | 95 | 45 (3) | 1,234 |
| 2017 | 24 | 70 | 22 (1) | 1,672 |
| 2018 | 19 | 156 | 1 | 1,903 |
| 2019 | 18 | 47 | 2 | 2,450 |
| 2020 | 9 | 49 | 21 (21) | 2,465 |
| 2021 | 12 | 78 | 6 | 2,835 |
| 2022 | 13 | 143 | 2 | 4,084 |
| 2023 | 15 | 55 | 10 | 3,775 |
| 2024 | 18 | 56 | 2 | 3,931 |
| 2025 | 16 | 63 | 3 | 4,539 |
| 2026 | 17 | 59 | 23 (21) | — |
What is it indicated for?
The Medikit Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets are indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K060190 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060190: Super Sheath XL Introducer Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060190
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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