510(k) · Cleared
ClearedSavvyWire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Opsens, Inc. · DQX Wire, Guide, Catheter
Cleared on Sep 14, 2022 as substantially equivalent to K151244 (Lake Region Medical, 2015) and 3 other predicates after a 278-day review. Its family tree reaches back 10 generations to 1982. 4 later devices descend from it.
- Decided
- Sep 14, 2022
- Review
- 278 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K823434 (1982). 38 ancestors in all, the oldest K800298 (1980). 4 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK823434 Mikro-Tip Catheter Pressure TransducerMillar Instruments, Inc. · 1982
- 6 generations between
- 3 generations backK192340 OptoMonitorOpsens, Inc. · 2019
- 2 generations backK193620 OptoMonitor 3Opsens, Inc. · 2020
- 1 generation backK202943 OptoMonitor 3Opsens, Inc. · 2020
- This deviceK213854 SavvyWireOpsens, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK241418 OptoMonitor 3Opsens, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK251367 OptoMonitor 3Opsens, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK252674 Solo Pace Fusion System (SOLOFUSE1)Solo Pace, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK240864 PacePro WireOpsens, Inc. · 2024
Show all 10 generations
- Root · 10 generations backK823434 Mikro-Tip Catheter Pressure TransducerMillar Instruments, Inc. · 1982
- 9 generations backK965140 Cardiometrics Wavewire/Wavemap Pressure SystemCardio Metrics, Inc. · 1997
- 8 generations backK021219 Smartwire/Smartmap Pressure SystemJomed, Inc. · 2002
- 7 generations backK070487 Smartwire Pressure Guide Wire, Model 66XXVolcano Corporation · 2007
- 6 generations backK100930 Primewire Prestiage Pressure Guide Wire, Models 8185, 8185J, 8300…Volcano Corporation · 2010
- 5 generations backK111395 Primewire Prestige PlusVolcano Corporation · 2011 · Recalled
- 4 generations backK142598 Opto Wire and OptoMonitor SystemOpsens, Inc. · 2015
- 3 generations backK192340 OptoMonitorOpsens, Inc. · 2019
- 2 generations backK193620 OptoMonitor 3Opsens, Inc. · 2020
- 1 generation backK202943 OptoMonitor 3Opsens, Inc. · 2020
- This deviceK213854 SavvyWireOpsens, Inc. · 2022
Most influential descendants
Showing 4 of 4 · See all- K241418OptoMonitor 3Opsens, Inc. · 2025 · cites it directly1descendant
- K251367OptoMonitor 3Opsens, Inc. · 2026 · 2 generations on0descendants
- K252674Solo Pace Fusion System (SOLOFUSE1)Solo Pace, Inc. · 2026 · cites it directly0descendants
- K240864PacePro WireOpsens, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K823434 | Mikro-Tip Catheter Pressure Transducer | Millar Instruments, Inc. | 1982 | — |
| −9 | K965140 | Cardiometrics Wavewire/Wavemap Pressure System | Cardio Metrics, Inc. | 1997 | — |
| −8 | K021219 | Smartwire/Smartmap Pressure System | Jomed, Inc. | 2002 | — |
| −7 | K070487 | Smartwire Pressure Guide Wire, Model 66XX | Volcano Corporation | 2007 | — |
| −6 | K100930 | Primewire Prestiage Pressure Guide Wire, Models 8185, 8185J, 8300, 8300J | Volcano Corporation | 2010 | — |
| −5 | K111395 | Primewire Prestige Plus | Volcano Corporation | 2011 | 1 |
| −4 | K142598 | Opto Wire and OptoMonitor System | Opsens, Inc. | 2015 | — |
| −3 | K192340 | OptoMonitor | Opsens, Inc. | 2019 | — |
| −2 | K193620 | OptoMonitor 3 | Opsens, Inc. | 2020 | — |
| −1 | K202943 | OptoMonitor 3 | Opsens, Inc. | 2020 | — |
| 0 (this device) | K213854 | SavvyWire | Opsens, Inc. | 2022 | — |
| +1 | K241418 | OptoMonitor 3 | Opsens, Inc. | 2025 | — |
| +2 | K251367 | OptoMonitor 3 | Opsens, Inc. | 2026 | — |
| +1 | K252674 | Solo Pace Fusion System (SOLOFUSE1) | Solo Pace, Inc. | 2026 | — |
| +1 | K240864 | PacePro Wire | Opsens, Inc. | 2024 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 K251181 Splashwire Hydrophilic Guide Wire…score 15.0 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K151244 | Pre-Formed GuidewireSummary page 5…eared in K192454 on 01/15/2020 [Secondary predicate], with the Lake Region Medical Pre- Formed Guidewire (Boston Scientific Safari2 Pre-Shaped TAVI Guidewire) cleared in K151244 on 06/11/2015 used as a primary reference device. The primary and secondary predicates (Predicate #1, Predicate #2) are included… | 2015 |
| * | K191907 | OptoWire IIISummary page 5…duct Code: DQX, DXO, LDF 3. PREDICATE DEVICE The proposed SavvyWire™ is substantially equivalent to the Opsens existing pressure guidewire, OptoWire III cleared in K191907 on 01/02/2020 [Primary Predicate], and the Wattson Temporary Pacing Guidewire cleared in K192454 on 01/15/2020 [Secondary predica… | 2020 |
| * | K192454 | Wattson Temporary Pacing GuidewireSummary page 5…alent to the Opsens existing pressure guidewire, OptoWire III cleared in K191907 on 01/02/2020 [Primary Predicate], and the Wattson Temporary Pacing Guidewire cleared in K192454 on 01/15/2020 [Secondary predicate], with the Lake Region Medical Pre- Formed Guidewire (Boston Scientific Safari2 Pre-Shaped TAV… | 2020 |
| * | K202943 | OptoMonitor 3Summary page 6…condary reference (Reference #2) device to support the pacing function. Bundled together with this new device is a minor change to the OptoMonitor 3 software included in K202943 cleared on 11/24/2020 (Predicate #3) which expands the software to include a separate TAVI interface for use with the new wire. T… | 2020 |
| † | K152784 | Pacel Bipolar Pacing Catheters | 2015 |
What descends from it? (4)
3 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 40 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- 5 of the 38 ancestors have a recall of any class.
- Of its descendants, K241418 (Opsens, Inc., 2025) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K151244.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 SavvyWire™ is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures, while measuring the pressure within the heart allowing calculation of hemodynamic parameters. Additionally, the SavvyWire™ can be used for temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart. The OptoMonitor 3 is…
Read the full statement (111 words)
The SavvyWire™ is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures, while measuring the pressure within the heart allowing calculation of hemodynamic parameters.
Additionally, the SavvyWire™ can be used for temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.
The OptoMonitor 3 is intended to measure cardiovascular blood pressure, including in heart chambers, coronary vessels and peripheral vessels, during interventional procedures.
Blood pressure measurements provide hemodynamic information, such as fractional flow reserve for the diagnosis and treatment of blood vessels and such as valve gradients during structural heart procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213854 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213854: SavvyWire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213854
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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