510(k) · Cleared
ClearedOpto Wire and OptoMonitor System
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 Jun 12, 2015 as substantially equivalent to K111395 (Volcano Corporation, 2011) and 1 other predicate after a 270-day review. Its family tree reaches back 6 generations to 1982. 12 later devices descend from it.
- Decided
- Jun 12, 2015
- Review
- 270 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K823434 (1982). 17 ancestors in all. 12 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK823434 Mikro-Tip Catheter Pressure TransducerMillar Instruments, Inc. · 1982
- 5 generations backK965140 Cardiometrics Wavewire/Wavemap Pressure SystemCardio Metrics, Inc. · 1997
- 4 generations backK021219 Smartwire/Smartmap Pressure SystemJomed, Inc. · 2002
- 3 generations backK070487 Smartwire Pressure Guide Wire, Model 66XXVolcano Corporation · 2007
- 2 generations backK100930 Primewire Prestiage Pressure Guide Wire, Models 8185, 8185J, 8300…Volcano Corporation · 2010
- 1 generation backK111395 Primewire Prestige PlusVolcano Corporation · 2011 · Recalled
- This deviceK142598 Opto Wire and OptoMonitor SystemOpsens, Inc. · 2015
- Descendant · cites it directly · 7 of its ownK192340 OptoMonitorOpsens, Inc. · 2019
- Descendant · 2 generations on · 6 of its ownK193620 OptoMonitor 3Opsens, Inc. · 2020
- Descendant · cites it directly · 6 of its ownK152991 OptoWire DeuxOpsens · 2016
- Descendant · 2 generations on · 5 of its ownK202943 OptoMonitor 3Opsens, Inc. · 2020
- Descendant · 2 generations on · 5 of its ownK191907 OptoWire IIIOpsens, Inc. · 2020
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K192340OptoMonitorOpsens, Inc. · 2019 · cites it directly7descendants
- K193620OptoMonitor 3Opsens, Inc. · 2020 · 2 generations on6descendants
- K152991OptoWire DeuxOpsens · 2016 · cites it directly6descendants
- K202943OptoMonitor 3Opsens, Inc. · 2020 · 2 generations on5descendants
- K191907OptoWire IIIOpsens, Inc. · 2020 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K823434 | Mikro-Tip Catheter Pressure Transducer | Millar Instruments, Inc. | 1982 | — |
| −5 | K965140 | Cardiometrics Wavewire/Wavemap Pressure System | Cardio Metrics, Inc. | 1997 | — |
| −4 | K021219 | Smartwire/Smartmap Pressure System | Jomed, Inc. | 2002 | — |
| −3 | K070487 | Smartwire Pressure Guide Wire, Model 66XX | Volcano Corporation | 2007 | — |
| −2 | K100930 | Primewire Prestiage Pressure Guide Wire, Models 8185, 8185J, 8300, 8300J | Volcano Corporation | 2010 | — |
| −1 | K111395 | Primewire Prestige Plus | Volcano Corporation | 2011 | 1 |
| 0 (this device) | K142598 | Opto Wire and OptoMonitor System | Opsens, Inc. | 2015 | — |
| +1 | K192340 | OptoMonitor | Opsens, Inc. | 2019 | — |
| +2 | K193620 | OptoMonitor 3 | Opsens, Inc. | 2020 | — |
| +1 | K152991 | OptoWire Deux | Opsens | 2016 | — |
| +2 | K202943 | OptoMonitor 3 | Opsens, Inc. | 2020 | — |
| +2 | K191907 | OptoWire III | Opsens, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K111395 | Primewire Prestige PlusSummary page 4…ode: DQX FDA Regulation: 21 CFR 870.1330 – Catheter Guide Wire Device Classification: Class II Premarket Notification: K111395 Product Name: ComboMap Pressure and Flow System (Volcano Corp.) Common Name: Intravascular P… | 2011 |
| * | K041134 | Combomap Pressure and Flow SystemSummary page 4…OBJ FDA Regulation: 21 CFR 870.1200 – Diagnostic Intravascular Catheter Device Classification: Class II Premarket Notification: K041134 Indications for Use: To measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angi… | 2004 |
What descends from it? (12)
See all 124 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 33 years and passes through 5 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 17 ancestors has a recall of any class.
- Of its descendants, K192340 (Opsens, Inc., 2019) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K111395.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
To measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or other any interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142598 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142598: Opto Wire and OptoMonitor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142598
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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