510(k) · Cleared
ClearedPrelude Plastic Jacketed Guide Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · DQX Wire, Guide, Catheter
Cleared on Dec 17, 2014 as substantially equivalent to K082644 (Terumo Medical Corp., 2008) after a 142-day review. Its family tree reaches back 4 generations to 1995. 1 of the 10 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 17, 2014
- Review
- 142 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K954234 (1995). 9 ancestors in all, the oldest K810675 (1981). No later device cites it as a predicate yet. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK954234 Radifocus Introducer II KitTerumo Medical Corp. · 1995
- 3 generations backK033681 GlidesheathTerumo Corp. · 2003
- 2 generations backK062858 Modification to GlidesheathTerumo Medical Corp. · 2006
- 1 generation backK082644 GlidesheathTerumo Medical Corp. · 2008
- This deviceK142051 Prelude Plastic Jacketed Guide WireMerit Medical Systems, Inc. · 2014
Class I recalls in this family
- K810675 Arrow Radial Artery Catheterization Set3 generations back · 1981
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954234 | Radifocus Introducer II Kit | Terumo Medical Corp. | 1995 | — |
| −3 | K033681 | Glidesheath | Terumo Corp. | 2003 | — |
| −2 | K062858 | Modification to Glidesheath | Terumo Medical Corp. | 2006 | — |
| −1 | K082644 | Glidesheath | Terumo Medical Corp. | 2008 | — |
| 0 (this device) | K142051 | Prelude Plastic Jacketed Guide Wire | Merit Medical Systems, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 1 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 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 DQX device
- #1 K213854 SavvyWirescore 15.7 · 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 |
|---|---|---|---|
| * | K082644 | GlidesheathSummary page 4…Classification Name: Wire, Guide, Catheter Premarket Notification Predicate Device # 1: Predicate Terumo Glidesheath(mini guide wire): K082644 Device Manufacturer: Terumo Medical Corporation Class II 21 CFR § 870.1330… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 3 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 6.2 years on median.
- 2 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
- 8 other devices also cite its predicate K082644.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DQX
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQX
177in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQX
3in 2024
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · DQX
2,178in 2025
MAUDE reports naming product code DQX, 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 | 14 | 85 | 12 | 760 |
| 2008 | 19 | 87 | 7 | 715 |
| 2009 | 18 | 87 | 49 | 687 |
| 2010 | 21 | 63 | 34 | 987 |
| 2011 | 18 | 43 | 3 | 1,311 |
| 2012 | 20 | 62 | 5 | 1,337 |
| 2013 | 18 | 119 | 7 (4) | 1,474 |
| 2014 | 18 | 103 | 0 | 1,323 |
| 2015 | 15 | 112 | 1 | 1,323 |
| 2016 | 14 | 179 | 2 (2) | 1,466 |
| 2017 | 19 | 85 | 17 | 1,524 |
| 2018 | 19 | 114 | 9 | 1,737 |
| 2019 | 13 | 173 | 2 | 1,679 |
| 2020 | 14 | 106 | 1 (1) | 1,536 |
| 2021 | 6 | 161 | 0 | 1,713 |
| 2022 | 15 | 212 | 0 | 1,647 |
| 2023 | 10 | 136 | 0 | 2,068 |
| 2024 | 11 | 134 | 3 | 2,210 |
| 2025 | 10 | 177 | 0 | 2,178 |
| 2026 | 12 | 145 | 4 (1) | — |
What is it indicated for?
The Merit plastic jacketed introducer guide wire is intended to facilitate the placement of devices during diagnostic and interventional procedures, specifically sheath introducers. The wire is indicated for the peripheral vasculature only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142051: Prelude Plastic Jacketed Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142051
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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