510(k) · Cleared
Recalled · Class II · 2024Prelude Guide Sheath
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 4, 2021 as substantially equivalent to K181463 (Contract Medical International, GmbH, 2018) after a 151-day review. Its family tree reaches back 8 generations to 1993. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Oct 4, 2021
- Review
- 151 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 8 generations to K924607 (1993). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK924607 Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc. · 1993 · Recalled
- 7 generations backK012812 Carotid Guiding SheathTerumo Medical Corp. · 2001 · Recalled
- 6 generations backK051601 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2005
- 5 generations backK080415 Device Modification to Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2008
- 4 generations backK091329 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2009 · Recalled
- 3 generations backK100799 Fortress Introducer Sheath System Model 358813, 358814, 358815Contract Medical Intl. GmbH · 2011
- 2 generations backK142357 DuraSheath Introducer Sheath SystemContract Medical International, GmbH · 2015
- 1 generation backK181463 DuraSheath Introducer Sheath SystemContract Medical International, GmbH · 2018
- This deviceK211405 Prelude Guide SheathMerit Medical Systems, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK223872 Low Profile Companion SheathMerit Medical Systems, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K223872Low Profile Companion SheathMerit Medical Systems, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K924607 | Arrow Fischell Kink Resist Percut Sheath Intro Set | Arrow Intl., Inc. | 1993 | 3 |
| −7 | K012812 | Carotid Guiding Sheath | Terumo Medical Corp. | 2001 | 1 |
| −6 | K051601 | Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2005 | — |
| −5 | K080415 | Device Modification to Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2008 | — |
| −4 | K091329 | Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2009 | 1 |
| −3 | K100799 | Fortress Introducer Sheath System Model 358813, 358814, 358815 | Contract Medical Intl. GmbH | 2011 | — |
| −2 | K142357 | DuraSheath Introducer Sheath System | Contract Medical International, GmbH | 2015 | — |
| −1 | K181463 | DuraSheath Introducer Sheath System | Contract Medical International, GmbH | 2018 | — |
| 0 (this device) | K211405 | Prelude Guide Sheath | Merit Medical Systems, Inc. | 2021 | — |
| +1 | K223872 | Low Profile Companion Sheath | Merit Medical Systems, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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.
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 |
|---|---|---|---|
| * | K181463 | DuraSheath Introducer Sheath SystemSummary page 4…Trade Name: DuraSheath Introducer Sheath System Classification Name: Catheter Introducer Premarket Notification: K181463 (Predicate) Predicate Manufacturer: Contract Medical International Device K… | 2018 |
| † | K091329 | Pinnacle Destination Peripheral Guiding Sheath | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223872 | Low Profile Companion Sheath | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 22, 2024 | Class II | Z-2218-2024 | Device Design | Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel nut detaching from the… |
| Mar 14, 2024 | Class II | Z-1874-2024 | Employee error | Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator. |
| Mar 14, 2024 | Class II | Z-1875-2024 | Employee error | Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K223872 (Merit Medical Systems, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K181463.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Prelude Guide Sheath Introducer is indicated to be used for the introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211405 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211405: Prelude Guide Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211405
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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