510(k) · Cleared
ClearedPrelude IDeal 9F Hydrophilic Sheath Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems · DYB Introducer, Catheter
Cleared on Jan 7, 2022 as substantially equivalent to K173750 (Merit Medical Systems, Inc., 2018) after a 182-day review. Its family tree reaches back 8 generations to 1995. 1 of the 20 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Jan 7, 2022
- Review
- 182 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K954234 (1995). 17 ancestors in all, the oldest K810675 (1981). 2 later devices descend from it, 1 citing it directly. 1 of the 20 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 deviceK212152 Prelude IDeal 9F Hydrophilic Sheath IntroducerMerit Medical Systems · 2022
- Descendant · cites it directly · 1 of its ownK232260 Thinline Sheath IntroducerInneuroco, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK261529 Micropuncture Kit / Micropuncture Access Kit / Micropuncture…Hartman Medical Group, LLC · 2026
Class I recalls in this family
- K810675 Arrow Radial Artery Catheterization Set6 generations back · 1981
Most influential descendants
Showing 2 of 2 · See allView 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) | K212152 | Prelude IDeal 9F Hydrophilic Sheath Introducer | Merit Medical Systems | 2022 | — |
| +1 | K232260 | Thinline Sheath Introducer | Inneuroco, Inc. | 2023 | — |
| +2 | 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 |
|---|---|---|
| 2023 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K173750 | Prelude IDeal Hydrophilic Sheath IntroducerSummary page 4…e Name: 9F Prelude IDeal™ Hydrophilic Sheath Introducer Predicate Classification Name: Catheter Introducer Device Premarket Notification: K173750 Manufacturer: Merit Medical Systems, Inc. Tradename: Flexor Check-Flo Intro… | 2018 |
| Kept off the family tree | K171750 | FDA’s K171750 is Citric Complete Dry Citric Acid (45X) Our reading of the summary gave K171750, FDA’s number for Citric Complete Dry Citric Acid (45X) (Dimesol USA, LLC). Its FDA name has none of the distinctive words the summary uses for the device it names, “Prelude IDeal™ Hydrophilic Sheath Introducer”. Kept off the family tree. Summary page 11…he predicate device and is substantially equivalent to the predicate device, Prelude IDeal™ Hydrophilic Sheath Introducer manufactured by Merit Medical Systems, Inc. (K171750). | 2018 |
| † | K142829 | Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer… | 2015 |
| † | K070159 | Prelude Sheath Introducer | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232260 | Thinline Sheath Introducer | 2023 | 1 |
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 27 years and passes through 4 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.
- Of its descendants, K232260 (Inneuroco, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 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. 2022, 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 9F Prelude IDeal Hydrophilic 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212152 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212152: Prelude IDeal 9F 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/K212152
Report an extraction error
Are you the manufacturer?
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