510(k) · Cleared
ClearedWattson Temporary Pacing Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Solutions · DQX Wire, Guide, Catheter
Cleared on Jan 15, 2020 as substantially equivalent to K181001 (Medtronic Core Valve, LLC, 2018) and 1 other predicate after a 128-day review. Its family tree reaches back 6 generations to 1992. 6 later devices descend from it.
- Decided
- Jan 15, 2020
- Review
- 128 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K920884 (1992). 11 ancestors in all, the oldest K800298 (1980). 6 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK920884 Guidewires, Various TypesAcme-Monaco Corp. · 1992
- 5 generations backK982559 GuidewireGalt Medical Corp. · 1999 · Recalled
- 4 generations backK042370 Torayguide GuidewireToray Industries (America), Inc. · 2004
- 3 generations backK132623 Medtronic Confida Brecker Curve GuidewireMedtronic · 2013
- 2 generations backK150465 Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC · 2015
- 1 generation backK181001 Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC · 2018
- This deviceK192454 Wattson Temporary Pacing GuidewireVascular Solutions · 2020
- Descendant · cites it directly · 4 of its ownK213854 SavvyWireOpsens, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK241418 OptoMonitor 3Opsens, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK251367 OptoMonitor 3Opsens, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK252674 Solo Pace Fusion System (SOLOFUSE1)Solo Pace, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK240864 PacePro WireOpsens, Inc. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K213854SavvyWireOpsens, Inc. · 2022 · cites it directly4descendants
- K241418OptoMonitor 3Opsens, Inc. · 2025 · 2 generations on1descendant
- K251367OptoMonitor 3Opsens, Inc. · 2026 · 3 generations on0descendants
- K252674Solo Pace Fusion System (SOLOFUSE1)Solo Pace, Inc. · 2026 · 2 generations on0descendants
- K240864PacePro WireOpsens, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K920884 | Guidewires, Various Types | Acme-Monaco Corp. | 1992 | — |
| −5 | K982559 | Guidewire | Galt Medical Corp. | 1999 | 1 |
| −4 | K042370 | Torayguide Guidewire | Toray Industries (America), Inc. | 2004 | — |
| −3 | K132623 | Medtronic Confida Brecker Curve Guidewire | Medtronic | 2013 | — |
| −2 | K150465 | Medtronic Confida Brecker Guidewire | Medtronic Core Valve, LLC | 2015 | — |
| −1 | K181001 | Medtronic Confida Brecker Guidewire | Medtronic Core Valve, LLC | 2018 | — |
| 0 (this device) | K192454 | Wattson Temporary Pacing Guidewire | Vascular Solutions | 2020 | — |
| +1 | K213854 | SavvyWire | Opsens, Inc. | 2022 | — |
| +2 | K241418 | OptoMonitor 3 | Opsens, Inc. | 2025 | — |
| +3 | K251367 | OptoMonitor 3 | Opsens, Inc. | 2026 | — |
| +2 | K252674 | Solo Pace Fusion System (SOLOFUSE1) | Solo Pace, Inc. | 2026 | — |
| +2 | K240864 | PacePro Wire | Opsens, Inc. | 2024 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K181001 | Medtronic Confida Brecker GuidewireSummary page 4…Primary Product Code: DQX Secondary Product Code: LDF PREDICATE DEVICES Primary Predicate: Manufacturer: Medtronic Device Name: Confida™ /Breaker Guidewire 510(k) No: K181001 (cleared May 3, 2018), Class II, Product Code DQX; classified per 21 CFR 870.1330… | 2018 |
| * | K800298 | Usci Bipolar Ballon Pacing ElectrodeSummary page 5…Page 1 of 6 Secondary Predicate: Manufacturer: Bard Device Name: Bard® Temporary Pacing Electrode Catheter 510(k) No: K800298 (cleared April 16, 1980), Class II, Product Code LDF; classified per 21 CFR 870.3680 DEVICE DESCRIPTION The Wattson temporary pac… | 1980 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 28 years and passes through 6 companies; a new generation was cleared every 5.9 years on median.
- 4 of the 11 ancestors have a recall of any class.
- Of its descendants, K213854 (Opsens, Inc., 2022) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K181001.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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/K192454 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192454: Wattson Temporary Pacing Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192454
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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