510(k) · Cleared
ClearedSolo Pace Fusion System (SOLOFUSE1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Solo Pace, Inc. · DQX Wire, Guide, Catheter
Cleared on Jan 9, 2026 as substantially equivalent to K213854 (Opsens, Inc., 2022) after a 137-day review. Its family tree reaches back 11 generations to 1982.
- Decided
- Jan 9, 2026
- Review
- 137 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K823434 (1982). 39 ancestors in all, the oldest K800298 (1980). No later device cites it as a predicate yet.
- Root · 11 generations backK823434 Mikro-Tip Catheter Pressure TransducerMillar Instruments, Inc. · 1982
- 7 generations between
- 3 generations backK193620 OptoMonitor 3Opsens, Inc. · 2020
- 2 generations backK202943 OptoMonitor 3Opsens, Inc. · 2020
- 1 generation backK213854 SavvyWireOpsens, Inc. · 2022
- This deviceK252674 Solo Pace Fusion System (SOLOFUSE1)Solo Pace, Inc. · 2026
Show all 11 generations
- Root · 11 generations backK823434 Mikro-Tip Catheter Pressure TransducerMillar Instruments, Inc. · 1982
- 10 generations backK965140 Cardiometrics Wavewire/Wavemap Pressure SystemCardio Metrics, Inc. · 1997
- 9 generations backK021219 Smartwire/Smartmap Pressure SystemJomed, Inc. · 2002
- 8 generations backK070487 Smartwire Pressure Guide Wire, Model 66XXVolcano Corporation · 2007
- 7 generations backK100930 Primewire Prestiage Pressure Guide Wire, Models 8185, 8185J, 8300…Volcano Corporation · 2010
- 6 generations backK111395 Primewire Prestige PlusVolcano Corporation · 2011 · Recalled
- 5 generations backK142598 Opto Wire and OptoMonitor SystemOpsens, Inc. · 2015
- 4 generations backK192340 OptoMonitorOpsens, Inc. · 2019
- 3 generations backK193620 OptoMonitor 3Opsens, Inc. · 2020
- 2 generations backK202943 OptoMonitor 3Opsens, Inc. · 2020
- 1 generation backK213854 SavvyWireOpsens, Inc. · 2022
- This deviceK252674 Solo Pace Fusion System (SOLOFUSE1)Solo Pace, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K823434 | Mikro-Tip Catheter Pressure Transducer | Millar Instruments, Inc. | 1982 | — |
| −10 | K965140 | Cardiometrics Wavewire/Wavemap Pressure System | Cardio Metrics, Inc. | 1997 | — |
| −9 | K021219 | Smartwire/Smartmap Pressure System | Jomed, Inc. | 2002 | — |
| −8 | K070487 | Smartwire Pressure Guide Wire, Model 66XX | Volcano Corporation | 2007 | — |
| −7 | K100930 | Primewire Prestiage Pressure Guide Wire, Models 8185, 8185J, 8300, 8300J | Volcano Corporation | 2010 | — |
| −6 | K111395 | Primewire Prestige Plus | Volcano Corporation | 2011 | 1 |
| −5 | K142598 | Opto Wire and OptoMonitor System | Opsens, Inc. | 2015 | — |
| −4 | K192340 | OptoMonitor | Opsens, Inc. | 2019 | — |
| −3 | K193620 | OptoMonitor 3 | Opsens, Inc. | 2020 | — |
| −2 | K202943 | OptoMonitor 3 | Opsens, Inc. | 2020 | — |
| −1 | K213854 | SavvyWire | Opsens, Inc. | 2022 | — |
| 0 (this device) | K252674 | Solo Pace Fusion System (SOLOFUSE1) | Solo Pace, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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? (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 |
|---|---|---|---|
| * | K213854 | SavvyWireSummary page 5…ire Classification Name 21 CFR 870.1330, Catheter Guidewire, DQX, Class II Secondary Product Code: LDF Predicate Device K213854, SavvyWire (Opsens Inc) Reference Device K230637 Wattson temporary pacing guidewire Reference Device K181… | 2022 |
| † | K230637 | Wattson temporary pacing guidewire (2250) | 2023 |
| † | K181001 | Medtronic Confida Brecker Guidewire | 2018 |
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 44 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
- 5 of the 39 ancestors have a recall of any class.
- 2 other devices also cite its predicate K213854.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Solo Pace Fusion is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures. Solo Pace Fusion can be used for temporary intracardiac pacing by transmitting an electrical signal from Solo Pace Control to the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252674 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252674: Solo Pace Fusion System (SOLOFUSE1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252674
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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