510(k) · Cleared
Recalled · Class II · 2016Preludeease 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 16, 2014 as substantially equivalent to K070159 (Merit Medical Systems, Inc., 2007) and 1 other predicate after a 226-day review. Its family tree reaches back 5 generations to 1995. 1 of the 21 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it. It has been recalled once.
- Decided
- Oct 16, 2014
- Review
- 226 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K954234 (1995). 14 ancestors in all, the oldest K810675 (1981). 6 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 · 5 generations backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
- 4 generations backK033681 GlidesheathTerumo Corp. · 2003
- 3 generations backK062858 Modification to GlidesheathTerumo Medical Corp. · 2006
- 2 generations backK082644 GlidesheathTerumo Medical Corp. · 2008
- 1 generation backK102008 GlidesheathTerumo Medical Corp. · 2010 · Recalled
- This deviceK140543 Preludeease Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. · 2014
- Descendant · cites it directly · 5 of its ownK150257 PreludeEASE Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. · 2015
- Descendant · cites it directly · 4 of its ownK173750 Prelude IDeal Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 2 of its ownK212152 Prelude IDeal 9F Hydrophilic Sheath IntroducerMerit Medical Systems · 2022
- Descendant · 3 generations on · 1 of its ownK232260 Thinline Sheath IntroducerInneuroco, Inc. · 2023
- Descendant · 4 generations on · 0 of its ownK261529 Micropuncture Kit / Micropuncture Access Kit / Micropuncture…Hartman Medical Group, LLC · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K810675 Arrow Radial Artery Catheterization Set4 generations back · 1981
Most influential descendants
Showing 5 of 6 · See all- K150257PreludeEASE Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. · 2015 · cites it directly5descendants
- K173750Prelude IDeal Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. · 2018 · cites it directly4descendants
- K212152Prelude IDeal 9F Hydrophilic Sheath IntroducerMerit Medical Systems · 2022 · 2 generations on2descendants
- K232260Thinline Sheath IntroducerInneuroco, Inc. · 2023 · 3 generations on1descendant
- K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/…Hartman Medical Group, LLC · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954234 | Radifocus Introducer II Kit | Terumo Medical Corp. | 1995 | — |
| −4 | K033681 | Glidesheath | Terumo Corp. | 2003 | — |
| −3 | K062858 | Modification to Glidesheath | Terumo Medical Corp. | 2006 | — |
| −2 | K082644 | Glidesheath | Terumo Medical Corp. | 2008 | — |
| −1 | K102008 | Glidesheath | Terumo Medical Corp. | 2010 | 1 |
| 0 (this device) | K140543 | Preludeease Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. | 2014 | — |
| +1 | K150257 | PreludeEASE Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. | 2015 | — |
| +1 | K173750 | Prelude IDeal Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. | 2018 | 2 |
| +2 | K212152 | Prelude IDeal 9F Hydrophilic Sheath Introducer | Merit Medical Systems | 2022 | — |
| +3 | K232260 | Thinline Sheath Introducer | Inneuroco, Inc. | 2023 | — |
| +4 | K261529 | Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/… | Hartman Medical Group, LLC | 2026 | — |
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 |
|---|---|---|
| 2015 | 1 | 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.
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 |
|---|---|---|---|
| * | K070159 | Prelude Sheath IntroducerSummary page 4…Classification Name: Vessel Dilator for Percutaneous Predicate Catheterization Device Premarket Notification: K070159 Manufacturer: Merit Medical Systems, Inc. Trade Name: Glideshe… | 2007 |
| * | K102008 | GlidesheathSummary page 4…Trade Name: Glidesheath Predicate Classification Name: Catheter Introducer Device Premarket Notification: K102008 Manufacturer: Terumo Medical Corporation Class II 21 C… | 2010 |
What descends from it? (6)
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 |
|---|---|---|---|---|
| Dec 1, 2016 | Class II | Z-0949-2017 | Process change control | Recalling dilators included with the 6F PreludeEASE Hydrophilic Sheath Introducer because the dilator tips were manufactured with an undersized inner diameter and therefore will not allow passage of an 0.021 (0.53 mm) guide wire. |
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 · 4 generations back · ◆ in the 1981 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 7 of the 14 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K150257 (Merit Medical Systems, Inc., 2015) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K070159.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 PreludeEASE 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K140543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140543: Preludeease 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/K140543
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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