510(k) · Cleared
ClearedPrelude and Prelude Pro Sheath Introducers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · DRE Dilator, Vessel, For Percutaneous Catheterization
Cleared on Nov 20, 2007 after a 22-day review. The FDA summary names its predicate without a number. 12 later devices descend from it.
- Decided
- Nov 20, 2007
- Review
- 22 days
- Class
- Class II
- Product code
- DRE
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 2 citing it directly.
- This deviceK073035 Prelude and Prelude Pro Sheath IntroducersMerit Medical Systems, Inc. · 2007
- Descendant · cites it directly · 10 of its ownK100799 Fortress Introducer Sheath System Model 358813, 358814, 358815Contract Medical Intl. GmbH · 2011
- Descendant · 2 generations on · 6 of its ownK142357 DuraSheath Introducer Sheath SystemContract Medical International, GmbH · 2015
- Descendant · 3 generations on · 5 of its ownK181463 DuraSheath Introducer Sheath SystemContract Medical International, GmbH · 2018
- Descendant · 4 generations on · 2 of its ownK221914 Catapult Guide SheathContract Medical International, GmbH · 2022
- Descendant · 2 generations on · 2 of its ownK153197 Fortress Introducer Sheath SYstemContract Medical International, GmbH · 2016 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K100799Fortress Introducer Sheath System Model 358813, 358814, 358815Contract Medical Intl. GmbH · 2011 · cites it directly10descendants
- K142357DuraSheath Introducer Sheath SystemContract Medical International, GmbH · 2015 · 2 generations on6descendants
- K181463DuraSheath Introducer Sheath SystemContract Medical International, GmbH · 2018 · 3 generations on5descendants
- K221914Catapult Guide SheathContract Medical International, GmbH · 2022 · 4 generations on2descendants
- K153197Fortress Introducer Sheath SYstemContract Medical International, GmbH · 2016 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K073035 | Prelude and Prelude Pro Sheath Introducers | Merit Medical Systems, Inc. | 2007 | — |
| +1 | K100799 | Fortress Introducer Sheath System Model 358813, 358814, 358815 | Contract Medical Intl. GmbH | 2011 | — |
| +2 | K142357 | DuraSheath Introducer Sheath System | Contract Medical International, GmbH | 2015 | — |
| +3 | K181463 | DuraSheath Introducer Sheath System | Contract Medical International, GmbH | 2018 | — |
| +4 | K221914 | Catapult Guide Sheath | Contract Medical International, GmbH | 2022 | — |
| +2 | K153197 | Fortress Introducer Sheath SYstem | Contract Medical International, GmbH | 2016 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | — | Prelude® Sheath Introducer Named without a submission number |
What descends from it? (12)
See all 122 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?
- Of its descendants, K100799 (Contract Medical Intl. GmbH, 2011) has gone furthest, with 10 descendants of its own.
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. 2007, 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 Prelude® Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073035 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073035: Prelude and Prelude Pro Sheath Introducers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073035
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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