510(k) · Cleared
ClearedFortress Introducer Sheath System Model 358813, 358814, 358815
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Contract Medical Intl. GmbH · DYB Introducer, Catheter
Cleared on Feb 25, 2011 as substantially equivalent to K073035 (Merit Medical Systems, Inc., 2007) and 1 other predicate after a 340-day review. Its family tree reaches back 5 generations to 1993. 10 later devices descend from it.
- Decided
- Feb 25, 2011
- Review
- 340 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K924607 (1993). 6 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK924607 Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc. · 1993 · Recalled
- 4 generations backK012812 Carotid Guiding SheathTerumo Medical Corp. · 2001 · Recalled
- 3 generations backK051601 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2005
- 2 generations backK080415 Device Modification to Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2008
- 1 generation backK091329 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2009 · Recalled
- This deviceK100799 Fortress Introducer Sheath System Model 358813, 358814, 358815Contract Medical Intl. GmbH · 2011
- Descendant · cites it directly · 6 of its ownK142357 DuraSheath Introducer Sheath SystemContract Medical International, GmbH · 2015
- Descendant · 2 generations on · 5 of its ownK181463 DuraSheath Introducer Sheath SystemContract Medical International, GmbH · 2018
- Descendant · 3 generations on · 2 of its ownK221914 Catapult Guide SheathContract Medical International, GmbH · 2022
- Descendant · cites it directly · 2 of its ownK153197 Fortress Introducer Sheath SYstemContract Medical International, GmbH · 2016 · Recalled
- Descendant · 4 generations on · 1 of its ownK240957 Catapult Guide SheathContract Medical International, GmbH · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K142357DuraSheath Introducer Sheath SystemContract Medical International, GmbH · 2015 · cites it directly6descendants
- K181463DuraSheath Introducer Sheath SystemContract Medical International, GmbH · 2018 · 2 generations on5descendants
- K221914Catapult Guide SheathContract Medical International, GmbH · 2022 · 3 generations on2descendants
- K153197Fortress Introducer Sheath SYstemContract Medical International, GmbH · 2016 · cites it directly2descendants
- K240957Catapult Guide SheathContract Medical International, GmbH · 2024 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K924607 | Arrow Fischell Kink Resist Percut Sheath Intro Set | Arrow Intl., Inc. | 1993 | 3 |
| −4 | K012812 | Carotid Guiding Sheath | Terumo Medical Corp. | 2001 | 1 |
| −3 | K051601 | Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2005 | — |
| −2 | K080415 | Device Modification to Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2008 | — |
| −1 | K091329 | Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2009 | 1 |
| 0 (this device) | K100799 | Fortress Introducer Sheath System Model 358813, 358814, 358815 | Contract Medical Intl. GmbH | 2011 | — |
| +1 | K142357 | DuraSheath Introducer Sheath System | Contract Medical International, GmbH | 2015 | — |
| +2 | K181463 | DuraSheath Introducer Sheath System | Contract Medical International, GmbH | 2018 | — |
| +3 | K221914 | Catapult Guide Sheath | Contract Medical International, GmbH | 2022 | — |
| +1 | K153197 | Fortress Introducer Sheath SYstem | Contract Medical International, GmbH | 2016 | 1 |
| +4 | K240957 | Catapult Guide Sheath | Contract Medical International, GmbH | 2024 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K073035 | Prelude and Prelude Pro Sheath IntroducersSummary page 1…d device to Manufacturer Device Name 510(k) Number which the device is Merit Medical Prelude and Prelude Pro K073035 substantially equivalent: Systems, Inc. Sheath Introducers Terumo Medica… | 2007 |
| * | K091329 | Pinnacle Destination Peripheral Guiding SheathSummary page 1…35 substantially equivalent: Systems, Inc. Sheath Introducers Terumo Medical Pinnacle Destination K091 329 Corporation Peripheral Guiding… | 2009 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K142357 (Contract Medical International, GmbH, 2015) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K073035.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Fortress Introducer Sheath System is intended to provide access and to facilitate percutaneous introduction of guide wires, catheters and other devices into the femoral, popliteal and infrapopliteal arteries while while maintaining hemostasis during diagnostic and interventional procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100799 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100799: Fortress Introducer Sheath System Model 358813, 358814, 358815.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100799
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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