510(k) · Cleared
ClearedWattson temporary pacing guidewire (2250)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Solutions, LLC · DQX Wire, Guide, Catheter
Cleared on May 5, 2023 as substantially equivalent to K192454 (Vascular Solutions, 2020) after a 59-day review. Its family tree reaches back 7 generations to 1992.
- Decided
- May 5, 2023
- Review
- 59 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K920884 (1992). 12 ancestors in all, the oldest K800298 (1980). No later device cites it as a predicate yet.
- Root · 7 generations backK920884 Guidewires, Various TypesAcme-Monaco Corp. · 1992
- 6 generations backK982559 GuidewireGalt Medical Corp. · 1999 · Recalled
- 5 generations backK042370 Torayguide GuidewireToray Industries (America), Inc. · 2004
- 4 generations backK132623 Medtronic Confida Brecker Curve GuidewireMedtronic · 2013
- 3 generations backK150465 Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC · 2015
- 2 generations backK181001 Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC · 2018
- 1 generation backK192454 Wattson Temporary Pacing GuidewireVascular Solutions · 2020
- This deviceK230637 Wattson temporary pacing guidewire (2250)Vascular Solutions, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K920884 | Guidewires, Various Types | Acme-Monaco Corp. | 1992 | — |
| −6 | K982559 | Guidewire | Galt Medical Corp. | 1999 | 1 |
| −5 | K042370 | Torayguide Guidewire | Toray Industries (America), Inc. | 2004 | — |
| −4 | K132623 | Medtronic Confida Brecker Curve Guidewire | Medtronic | 2013 | — |
| −3 | K150465 | Medtronic Confida Brecker Guidewire | Medtronic Core Valve, LLC | 2015 | — |
| −2 | K181001 | Medtronic Confida Brecker Guidewire | Medtronic Core Valve, LLC | 2018 | — |
| −1 | K192454 | Wattson Temporary Pacing Guidewire | Vascular Solutions | 2020 | — |
| 0 (this device) | K230637 | Wattson temporary pacing guidewire (2250) | Vascular Solutions, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 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 DQX? 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 |
|---|---|---|---|
| * | K192454 | Wattson Temporary Pacing GuidewireSummary page 4…er Guidewire Classification Name 21 CFR 870.1330, Catheter Guidewire, DQX, Class II Secondary Product Code: LDF Predicate Device K192454, Wattson temporary pacing guidewire (Vascular Solutions LLC) Device Description The Wattson temporary pacing guidewire is a dua… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 7 companies; a new generation was cleared every 3.3 years on median.
- 4 of the 12 ancestors have a recall of any class.
- 1 other device also cites its predicate K192454.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Wattson temporary pacing guidewire is intended to introduce and position catheters and other interventional devices within the chambers of the heart, including those used within transcatheter aortic valve replacement (TAVR) procedures and balloon aortic valvuloplasty (BAV), while transmitting an electrical signal from an external pulse generator to the heart. The temporary pacing guidewire is not intended to remain in place following the clinical procedure.
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/K230637 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230637: Wattson temporary pacing guidewire (2250).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230637
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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