510(k) · Cleared
Recalled · Class I · 2021Prelude Short 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 15, 2008 as substantially equivalent to K961780 (Thomas Medical Products, Inc., 1996) after an 86-day review. Its family tree reaches back 1 generation to 1996. 1 of the 3 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 19 times, including a Class I recall.
- Decided
- Oct 15, 2008
- Review
- 86 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 19 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961780 (1996). 1 later device descends from it, 1 citing it directly. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK961780 Hemodialysis Introducer SetThomas Medical Products, Inc. · 1996
- This deviceK082063 Prelude Short Sheath IntroducerMerit Medical Systems, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK122190 Prelude 7F Short Sheath IntroducerMerit Medical Systems, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K122190Prelude 7F Short Sheath IntroducerMerit Medical Systems, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961780 | Hemodialysis Introducer Set | Thomas Medical Products, Inc. | 1996 | — |
| 0 (this device) | K082063 | Prelude Short Sheath Introducer | Merit Medical Systems, Inc. | 2008 | — |
| +1 | K122190 | Prelude 7F Short Sheath Introducer | Merit Medical Systems, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 |
|---|---|---|---|
| * | K961780 | Hemodialysis Introducer SetSummary page 1…Cardiovascular PREDICATE DEVICE(S) Hemodialysis Introducer Set (Distributed as DialEaseTM Introducer Sheath), K961780 DEVICE DESCRIPTION The Prelude® Short Sheath Introducer (PSS) consists of a sheath introducer with integral he… | 1996 |
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 |
|---|---|---|---|
| K122190 | Prelude 7F Short Sheath Introducer | 2012 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 21, 2021 | Class II | Z-2243-2021 | Process control | There is a potential that a package sheath contains an incorrect dilator. |
| Feb 16, 2017 | Class I | Z-1497-2017 | Process control | Merit Medical Systems, Inc. announces a voluntary field action for sheaths included with the 7F Prelude¿ Short Sheath Introducers because the sheath marker tips may detach during use. |
| Dec 17, 2010 | Not classified | Z-0941-2011 | Component change control | Introducer tips may detach and embolize during use, or the tip material may elicit a thrombogenic response. |
| Sep 29, 2009 | Not classified | Z-0518-2010 | Other | Potential sterility breach caused by excessive shipment damage. |
| Sep 29, 2009 | Not classified | Z-0517-2010 | Other | Potential sterility breach caused by excessive shipment damage. |
| Apr 14, 2009 | Not classified | Z-1406-2009 | Process control | External tubing may separate during use, allowing blood loss. |
| Apr 14, 2009 | Not classified | Z-1404-2009 | Process control | External tubing may separate during use, allowing blood loss. |
| Apr 14, 2009 | Not classified | Z-1403-2009 | Process control | External tubing may separate during use, allowing blood loss. |
| Apr 14, 2009 | Not classified | Z-1407-2009 | Process control | External tubing may separate during use, allowing blood loss. |
| Apr 14, 2009 | Not classified | Z-1408-2009 | Process control | External tubing may separate during use, allowing blood loss. |
| Apr 14, 2009 | Not classified | Z-1414-2009 | Process control | External tubing may separate during use, allowing blood loss. |
| Apr 14, 2009 | Not classified | Z-1415-2009 | Process control | External tubing may separate during use, allowing blood loss. |
| Apr 14, 2009 | Not classified | Z-1413-2009 | Process control | External tubing may separate during use, allowing blood loss. |
| Apr 14, 2009 | Not classified | Z-1402-2009 | Process control | External tubing may separate during use, allowing blood loss. |
| Apr 14, 2009 | Not classified | Z-1410-2009 | Process control | External tubing may separate during use, allowing blood loss. |
| Apr 14, 2009 | Not classified | Z-1409-2009 | Process control | External tubing may separate during use, allowing blood loss. |
| Apr 14, 2009 | Not classified | Z-1647-2009 | Process control | External tubing may separate during use, allowing blood loss. |
| Apr 14, 2009 | Not classified | Z-1405-2009 | Process control | External tubing may separate during use, allowing blood loss. |
| Apr 14, 2009 | Not classified | Z-1412-2009 | Process control | External tubing may separate during use, allowing blood loss. |
The 5 latest of 19 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K122190 (Merit Medical Systems, Inc., 2012) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Merit's Prelude® Short 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. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. The device is not indicated for long term vascular or hemodialysis access.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082063 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082063: Prelude Short 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/K082063
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