510(k) · Cleared
ClearedPrelude Wave 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 Apr 25, 2025 as substantially equivalent to K173750 (Merit Medical Systems, Inc., 2018) after a 30-day review. Its family tree reaches back 8 generations to 1995. 1 of the 18 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 25, 2025
- Review
- 30 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K954234 (1995). 17 ancestors in all, the oldest K810675 (1981). No later device cites it as a predicate yet. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
- 7 generations backK033681 GlidesheathTerumo Corp. · 2003
- 6 generations backK062858 Modification to GlidesheathTerumo Medical Corp. · 2006
- 5 generations backK082644 GlidesheathTerumo Medical Corp. · 2008
- 4 generations backK102008 GlidesheathTerumo Medical Corp. · 2010 · Recalled
- 3 generations backK140543 Preludeease Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. · 2014 · Recalled
- 2 generations backK150257 PreludeEASE Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. · 2015
- 1 generation backK173750 Prelude IDeal Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. · 2018 · Recalled
- This deviceK250909 Prelude Wave Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. · 2025
Class I recalls in this family
- K810675 Arrow Radial Artery Catheterization Set6 generations back · 1981
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K954234 | Radifocus Introducer II Kit | Terumo Medical Corp. | 1995 | — |
| −7 | K033681 | Glidesheath | Terumo Corp. | 2003 | — |
| −6 | K062858 | Modification to Glidesheath | Terumo Medical Corp. | 2006 | — |
| −5 | K082644 | Glidesheath | Terumo Medical Corp. | 2008 | — |
| −4 | K102008 | Glidesheath | Terumo Medical Corp. | 2010 | 1 |
| −3 | K140543 | Preludeease Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. | 2014 | 1 |
| −2 | K150257 | PreludeEASE Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. | 2015 | — |
| −1 | K173750 | Prelude IDeal Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. | 2018 | 2 |
| 0 (this device) | K250909 | Prelude Wave Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 1 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K173750 | Prelude IDeal Hydrophilic Sheath IntroducerSummary page 5…e IDeal Hydrophilic Sheath Introducer Predicate Device Common/Usual Name: Sheath Introducer Premarket K173750 Notification: Manufacturer: Merit Medical Systems, Inc. This predi… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K810675Arrow Radial Artery Catheterization SetArrow Intl., Inc. · 1981 · 6 generations back · ◆ in the 1981 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 9 of the 17 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K173750.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Merit Prelude Wave Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guidewires.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250909 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250909: Prelude Wave 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/K250909
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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