510(k) · Cleared
ClearedPtfe Super Sheath Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Martech Medical Products · DYB Introducer, Catheter
Cleared on Jul 29, 2013 as substantially equivalent to K120617 (Martech Medical Products, 2012) and 1 other predicate after a 123-day review. Its family tree reaches back 6 generations to 1993. 1 later device descends from it.
- Decided
- Jul 29, 2013
- Review
- 123 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K932323 (1993). 15 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK932323 Percutaneous IntroducerMedamicus, Inc. · 1993
- 5 generations backK021004 Valved Peelable IntroducerMedamicus, Inc. · 2002
- 4 generations backK030905 Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2003
- 3 generations backK040150 Modification to Medamicus Flowguard Peelable IntroducerMedamicus, Inc. · 2004
- 2 generations backK090394 Valved Tearway IntroducerMedcomp · 2009
- 1 generation backK120617 Ptfe Super Sheath IntroducerMartech Medical Products · 2012
- This deviceK130855 Ptfe Super Sheath IntroducerMartech Medical Products · 2013
- Descendant · cites it directly · 0 of its ownK153246 PTFE Super Sheath Introducer 2.1Medcomp (Medical Components, Inc.) · 2016
Most influential descendants
Showing 1 of 1 · See all- K153246PTFE Super Sheath Introducer 2.1Medcomp (Medical Components, Inc.) · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K932323 | Percutaneous Introducer | Medamicus, Inc. | 1993 | — |
| −5 | K021004 | Valved Peelable Introducer | Medamicus, Inc. | 2002 | — |
| −4 | K030905 | Medamicus Flowguard Peelable Introducer | Medamicus, Inc. | 2003 | — |
| −3 | K040150 | Modification to Medamicus Flowguard Peelable Introducer | Medamicus, Inc. | 2004 | — |
| −2 | K090394 | Valved Tearway Introducer | Medcomp | 2009 | — |
| −1 | K120617 | Ptfe Super Sheath Introducer | Martech Medical Products | 2012 | — |
| 0 (this device) | K130855 | Ptfe Super Sheath Introducer | Martech Medical Products | 2013 | — |
| +1 | K153246 | PTFE Super Sheath Introducer 2.1 | Medcomp (Medical Components, Inc.) | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (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 |
|---|---|---|---|
| * | K120617 | Ptfe Super Sheath IntroducerSummary page 2…on, general design, and materials. The. PTFE Super Sheath Introducer 2.0 differs from its Martech PTBE Super Sheath Introducer 5101K120617 predicate in regards to minor dimensional changes and material changes for physician preferences, The original… | 2012 |
| * | K091954 | Micro-Stick SetSummary page 1…DYE; EI C. Predicate Devices: K(120617: Martech, PTFE Super Sheatha Introducer K091954: Medcomp, Micro-Stick Set D. Device Description: The PTFE Super Sheath Introducer With Shea… | 2010 |
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 |
|---|---|---|---|
| K153246 | PTFE Super Sheath Introducer 2.1 | 2016 | 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 3 companies; a new generation was cleared every 3.2 years on median.
- 4 of the 15 ancestors have a recall of any class.
- Of its descendants, K153246 (Medcomp (Medical Components, Inc.), 2016) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 PTFE Super Sheath Introducers are intended to obtain central venous access to facilitate catheter insertion or placing pacing leads into the central venous system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130855 · printed Nov 3, 2026
Cite this page
510(k) Report. “K130855: Ptfe Super Sheath Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K130855
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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