510(k) · Cleared
ClearedDuraSheath Introducer Sheath System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Contract Medical International, GmbH · DYB Introducer, Catheter
Cleared on Jun 25, 2015 as substantially equivalent to K091329 (Terumo Medical Corp., 2009) and 1 other predicate after a 304-day review. Its family tree reaches back 6 generations to 1993. 6 later devices descend from it.
- Decided
- Jun 25, 2015
- Review
- 304 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K924607 (1993). 7 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK924607 Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc. · 1993 · Recalled
- 5 generations backK012812 Carotid Guiding SheathTerumo Medical Corp. · 2001 · Recalled
- 4 generations backK051601 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2005
- 3 generations backK080415 Device Modification to Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2008
- 2 generations backK091329 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2009 · Recalled
- 1 generation backK100799 Fortress Introducer Sheath System Model 358813, 358814, 358815Contract Medical Intl. GmbH · 2011
- This deviceK142357 DuraSheath Introducer Sheath SystemContract Medical International, GmbH · 2015
- Descendant · cites it directly · 5 of its ownK181463 DuraSheath Introducer Sheath SystemContract Medical International, GmbH · 2018
- Descendant · 2 generations on · 2 of its ownK221914 Catapult Guide SheathContract Medical International, GmbH · 2022
- Descendant · 3 generations on · 1 of its ownK240957 Catapult Guide SheathContract Medical International, GmbH · 2024
- Descendant · 2 generations on · 1 of its ownK211405 Prelude Guide SheathMerit Medical Systems, Inc. · 2021 · Recalled
- Descendant · 4 generations on · 0 of its ownK250439 Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide…Contract Medical International, GmbH · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K181463DuraSheath Introducer Sheath SystemContract Medical International, GmbH · 2018 · cites it directly5descendants
- K221914Catapult Guide SheathContract Medical International, GmbH · 2022 · 2 generations on2descendants
- K240957Catapult Guide SheathContract Medical International, GmbH · 2024 · 3 generations on1descendant
- K211405Prelude Guide SheathMerit Medical Systems, Inc. · 2021 · 2 generations on1descendant
- K250439Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm…Contract Medical International, GmbH · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K924607 | Arrow Fischell Kink Resist Percut Sheath Intro Set | Arrow Intl., Inc. | 1993 | 3 |
| −5 | K012812 | Carotid Guiding Sheath | Terumo Medical Corp. | 2001 | 1 |
| −4 | K051601 | Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2005 | — |
| −3 | K080415 | Device Modification to Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2008 | — |
| −2 | K091329 | Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2009 | 1 |
| −1 | K100799 | Fortress Introducer Sheath System Model 358813, 358814, 358815 | Contract Medical Intl. GmbH | 2011 | — |
| 0 (this device) | K142357 | DuraSheath Introducer Sheath System | Contract Medical International, GmbH | 2015 | — |
| +1 | K181463 | DuraSheath Introducer Sheath System | Contract Medical International, GmbH | 2018 | — |
| +2 | K221914 | Catapult Guide Sheath | Contract Medical International, GmbH | 2022 | — |
| +3 | K240957 | Catapult Guide Sheath | Contract Medical International, GmbH | 2024 | — |
| +2 | K211405 | Prelude Guide Sheath | Merit Medical Systems, Inc. | 2021 | 3 |
| +4 | K250439 | Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F… | Contract Medical International, GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K091329 | Pinnacle Destination Peripheral Guiding SheathSummary page 4…DYB; and DRE 1.3 Predicate Device Primary Predicate Device: Pinnacle Destination Guiding Sheaths (K091329) Second Predicate Device: Fortress Introducer Sheath System (K100799) 1.4 Device Descriptio… | 2009 |
| * | K100799 | Fortress Introducer Sheath System Model 358813, 358814, 358815Summary page 4…nnacle Destination Guiding Sheaths (K091329) Second Predicate Device: Fortress Introducer Sheath System (K100799) 1.4 Device Description The DuraSheath Introducer Sheath System is a sterile, disposable device consisting of (a) a coil rein… | 2011 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181463 | DuraSheath Introducer Sheath System | 2018 | 5 |
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 22 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K181463 (Contract Medical International, GmbH, 2018) has gone furthest, with 5 descendants of its own.
- 7 other devices also cite its predicate K091329.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 DuraSheath Introducer Sheath System is indicated to be used for introduction of interventional and diagnostic devices into the human vasculature, including but not limited to femoral access via a contralateral approach to access the popliteal and infrapopliteal arteries.
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/K142357 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142357: DuraSheath Introducer Sheath System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142357
Report an extraction error
Are you the manufacturer?
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