510(k) · Cleared
Recalled · Class II · 2025Prelude IDeal 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 Feb 15, 2018 as substantially equivalent to K140543 (Merit Medical Systems, Inc., 2014) and 1 other predicate after a 69-day review. Its family tree reaches back 7 generations to 1995. 1 of the 21 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 15, 2018
- Review
- 69 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 7 generations to K954234 (1995). 16 ancestors in all, the oldest K810675 (1981). 4 later devices descend from it, 2 citing it directly. 1 of the 21 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
- 6 generations backK033681 GlidesheathTerumo Corp. · 2003
- 5 generations backK062858 Modification to GlidesheathTerumo Medical Corp. · 2006
- 4 generations backK082644 GlidesheathTerumo Medical Corp. · 2008
- 3 generations backK102008 GlidesheathTerumo Medical Corp. · 2010 · Recalled
- 2 generations backK140543 Preludeease Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. · 2014 · Recalled
- 1 generation backK150257 PreludeEASE Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. · 2015
- This deviceK173750 Prelude IDeal Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK212152 Prelude IDeal 9F Hydrophilic Sheath IntroducerMerit Medical Systems · 2022
- Descendant · 2 generations on · 1 of its ownK232260 Thinline Sheath IntroducerInneuroco, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK261529 Micropuncture Kit / Micropuncture Access Kit / Micropuncture…Hartman Medical Group, LLC · 2026
- Descendant · cites it directly · 0 of its ownK250909 Prelude Wave Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. · 2025
Class I recalls in this family
- K810675 Arrow Radial Artery Catheterization Set5 generations back · 1981
Most influential descendants
Showing 4 of 4 · See all- K212152Prelude IDeal 9F Hydrophilic Sheath IntroducerMerit Medical Systems · 2022 · cites it directly2descendants
- K232260Thinline Sheath IntroducerInneuroco, Inc. · 2023 · 2 generations on1descendant
- K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/…Hartman Medical Group, LLC · 2026 · 3 generations on0descendants
- K250909Prelude Wave Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K954234 | Radifocus Introducer II Kit | Terumo Medical Corp. | 1995 | — |
| −6 | K033681 | Glidesheath | Terumo Corp. | 2003 | — |
| −5 | K062858 | Modification to Glidesheath | Terumo Medical Corp. | 2006 | — |
| −4 | K082644 | Glidesheath | Terumo Medical Corp. | 2008 | — |
| −3 | K102008 | Glidesheath | Terumo Medical Corp. | 2010 | 1 |
| −2 | K140543 | Preludeease Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. | 2014 | 1 |
| −1 | K150257 | PreludeEASE Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. | 2015 | — |
| 0 (this device) | K173750 | Prelude IDeal Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. | 2018 | — |
| +1 | K212152 | Prelude IDeal 9F Hydrophilic Sheath Introducer | Merit Medical Systems | 2022 | — |
| +2 | K232260 | Thinline Sheath Introducer | Inneuroco, Inc. | 2023 | — |
| +3 | K261529 | Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/… | Hartman Medical Group, LLC | 2026 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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? (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 |
|---|---|---|---|
| * | K140543 | Preludeease Hydrophilic Sheath IntroducerSummary page 4…ame: PreludeEASE™ Hydrophilic Sheath Introducer Classification Name: Sheath Introducer Predicate Premarket Notification: K140543 (Primary Predicate Device) Device K150257 (Secondary Predicate Device)… | 2014 |
| * | K150257 | PreludeEASE Hydrophilic Sheath IntroducerSummary page 4…Classification Name: Sheath Introducer Predicate Premarket Notification: K140543 (Primary Predicate Device) Device K150257 (Secondary Predicate Device) Manufacturer: Merit Medical Systems, Inc. Thi… | 2015 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 27, 2025 | Class II | Z-1434-2025 | Packaging process control | Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay. |
| Sep 12, 2019 | Class II | Z-1956-2020 | Process control | labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included in the product packaging. The use of the incorrect kit components may… |
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 · 5 generations back · ◆ in the 1981 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 8 of the 16 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K212152 (Merit Medical Systems, 2022) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K140543.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 IDeal 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 guide wires.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173750 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173750: Prelude IDeal 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/K173750
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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