510(k) · Cleared
Recalled · Class II · 2024Prelude SNAP Splittable Hydrophilic Sheath Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · DYB Introducer, Catheter
Cleared on Oct 30, 2015 as substantially equivalent to K143255 (Merit Medical Systems, Inc., 2015) after a 67-day review. Its family tree reaches back 2 generations to 1994. It has been recalled 2 times.
- Decided
- Oct 30, 2015
- Review
- 67 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K934901 (1994). No later device cites it as a predicate yet.
- Root · 2 generations backK934901 Tear-Away Sheath Introducer Set with Integral Hemostasis ValveThomas Medical Products, Inc. · 1994 · Recalled
- 1 generation backK143255 Prelude SNAP Splittable Sheath IntroducerMerit Medical Systems, Inc. · 2015 · Recalled
- This deviceK152381 Prelude SNAP Splittable Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K934901 | Tear-Away Sheath Introducer Set with Integral Hemostasis Valve | Thomas Medical Products, Inc. | 1994 | 7 |
| −1 | K143255 | Prelude SNAP Splittable Sheath Introducer | Merit Medical Systems, Inc. | 2015 | 4 |
| 0 (this device) | K152381 | Prelude SNAP Splittable Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. | 2015 | — |
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? (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 |
|---|---|---|---|
| * | K143255 | Prelude SNAP Splittable Sheath IntroducerSummary page 4…relude SNAP™ Splittable Sheath Introducer Predicate Classification Name: Introducer, Catheter (21 CFR §870.1340) Device Premarket Notification: K143255 - Prelude SNAP™ Splittable Sheath Introducer Manufacturer:… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 11, 2024 | Class II | Z-2575-2024 | No Marketing Application | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. |
| Dec 14, 2017 | Class II | Z-0688-2018 | Under Investigation by firm | Merit Medical Systems, Inc. is voluntarily conducting a recall of specific lots of Prelude SNAP Splittable Sheath Introducers due to an intermittent failure of the splittable hub. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 21.2 years on median.
- 2 of the 2 ancestors have a recall of any class.
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?
For the introduction of various types of pacing leads and catheters to the heart and coronary venous system
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152381: Prelude SNAP Splittable Hydrophilic 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/K152381
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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