510(k) · Cleared
Recalled · Class II · 2024Prelude Sheath Introducer
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 Jun 21, 2007 as substantially equivalent to K050962 (Merit Medical Systems, Inc., 2005) after a 155-day review. Its family tree reaches back 3 generations to 1995. 22 later devices descend from it. It has been recalled 3 times.
- Decided
- Jun 21, 2007
- Review
- 155 days
- Class
- Class II
- Product code
- DRE
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 3 generations to K945616 (1995). 4 ancestors in all. 22 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK945616 Cordis Avanti Catheter Sheath IntroducerCordis Corp. · 1995 · Recalled
- 2 generations backK970392 Cordis Avanti+Catheter Sheath Introducer SystemCordis Corp. · 1997 · Recalled
- 1 generation backK050962 Merit Prelude Sheath IntroducerMerit Medical Systems, Inc. · 2005 · Recalled
- This deviceK070159 Prelude Sheath IntroducerMerit Medical Systems, Inc. · 2007
- 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 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · 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 |
|---|---|---|---|---|---|
| −3 | K945616 | Cordis Avanti Catheter Sheath Introducer | Cordis Corp. | 1995 | 1 |
| −2 | K970392 | Cordis Avanti+Catheter Sheath Introducer System | Cordis Corp. | 1997 | 2 |
| −1 | K050962 | Merit Prelude Sheath Introducer | Merit Medical Systems, Inc. | 2005 | 1 |
| 0 (this device) | K070159 | Prelude Sheath Introducer | Merit Medical Systems, Inc. | 2007 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K050962 | Merit Prelude Sheath IntroducerSummary page 1…Class II, Product Code DRE (per 21 CFR 870.1310) Predicate Device PreludeTM Sheath Introducer (1(050962), manufactured by Merit Medical Systems, Inc.… | 2005 |
What descends from it? (22)
See all 225 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 12, 2024 | Class II | Z-3190-2024 | Labeling mix-ups | 7F sheath introducers labeled as 7.5F |
| Mar 21, 2023 | Class II | Z-1578-2023 | Unknown/Undetermined by firm | Custom sheath Introducer contains incorrect needle size |
| Jun 4, 2015 | Class II | Z-1826-2015 | Packaging process control | Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. This affects one lot, H767887, of catalog number PR0-6F-11-038. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 4 of the 4 ancestors have a recall of any class.
- Of its descendants, K091006 (Arstasis, Inc., 2010) has gone furthest, with 12 descendants of its own.
- 1 other device also cites its predicate K050962.
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 Merit PreludeTM 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/K070159 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070159: Prelude Sheath Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070159
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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