510(k) · Cleared
ClearedOptoMonitor II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Opsens, Inc. · DXO Transducer, Pressure, Catheter Tip
Cleared on Sep 13, 2016 as substantially equivalent to K142598 (Opsens, Inc., 2015) and 2 other predicates after a 131-day review. Its family tree reaches back 7 generations to 1982.
- Decided
- Sep 13, 2016
- Review
- 131 days
- Class
- Class II
- Product code
- DXO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K823434 (1982). 18 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK823434 Mikro-Tip Catheter Pressure TransducerMillar Instruments, Inc. · 1982
- 6 generations backK965140 Cardiometrics Wavewire/Wavemap Pressure SystemCardio Metrics, Inc. · 1997
- 5 generations backK021219 Smartwire/Smartmap Pressure SystemJomed, Inc. · 2002
- 4 generations backK070487 Smartwire Pressure Guide Wire, Model 66XXVolcano Corporation · 2007
- 3 generations backK100930 Primewire Prestiage Pressure Guide Wire, Models 8185, 8185J, 8300…Volcano Corporation · 2010
- 2 generations backK111395 Primewire Prestige PlusVolcano Corporation · 2011 · Recalled
- 1 generation backK142598 Opto Wire and OptoMonitor SystemOpsens, Inc. · 2015
- This deviceK161263 OptoMonitor IIOpsens, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K823434 | Mikro-Tip Catheter Pressure Transducer | Millar Instruments, Inc. | 1982 | — |
| −6 | K965140 | Cardiometrics Wavewire/Wavemap Pressure System | Cardio Metrics, Inc. | 1997 | — |
| −5 | K021219 | Smartwire/Smartmap Pressure System | Jomed, Inc. | 2002 | — |
| −4 | K070487 | Smartwire Pressure Guide Wire, Model 66XX | Volcano Corporation | 2007 | — |
| −3 | K100930 | Primewire Prestiage Pressure Guide Wire, Models 8185, 8185J, 8300, 8300J | Volcano Corporation | 2010 | — |
| −2 | K111395 | Primewire Prestige Plus | Volcano Corporation | 2011 | 1 |
| −1 | K142598 | Opto Wire and OptoMonitor System | Opsens, Inc. | 2015 | — |
| 0 (this device) | K161263 | OptoMonitor II | Opsens, Inc. | 2016 | — |
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 |
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 DXO? 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 DXO device
- #1 K241418 OptoMonitor 3score 14.8 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K142598 | Opto Wire and OptoMonitor SystemSummary page 4…cation name: transducer, pressure, catheter tip (870.2870) Regulatory Class: II Product Code: DXO 7.3 PREDICATE DEVICE OptoMonitor System cleared via K142598 (cleared on 06/12/2015). This predicate has not been subject to a design-related recall. No reference devices were used in this s… | 2015 |
| * | K111395 | Primewire Prestige PlusSummary page 7…Pending K142598 Predicates K142598 K111395 K041134… | 2011 |
| * | K041134 | Combomap Pressure and Flow SystemSummary page 7…K142598 K111395 K041134 Product Code DXO DQX, DXO… | 2004 |
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 34 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 18 ancestors has a recall of any class.
- 3 other devices also cite its predicate K142598.
How does its category compare?
All DXO devicesDXO Transducer, Pressure, Catheter Tip: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · DXO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXO
120in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXO
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXO
183in 2025
MAUDE reports naming product code DXO, 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 | 1 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 8 |
| 2010 | 1 | — | 0 | 74 |
| 2011 | 1 | — | 0 | 111 |
| 2012 | 1 | — | 0 | 82 |
| 2013 | 1 | — | 0 | 93 |
| 2014 | 3 | 176 | 0 | 85 |
| 2015 | 2 | — | 1 | 114 |
| 2016 | 2 | — | 0 | 152 |
| 2017 | 2 | — | 0 | 186 |
| 2018 | 1 | — | 0 | 179 |
| 2019 | 4 | 120 | 0 | 153 |
| 2020 | 2 | — | 0 | 158 |
| 2021 | 0 | — | 0 | 116 |
| 2022 | 1 | — | 0 | 144 |
| 2023 | 0 | — | 0 | 194 |
| 2024 | 1 | — | 0 | 197 |
| 2025 | 1 | — | 0 | 183 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The OptoMonitor 2 is a system intended for use in all blood vessels, including coronary and peripheral vasculature, to measure intravascular pressure during angiography and/or interventional procedures.
Pressure measurements are obtained to provide hemodynamic information, such as FFR, for the diagnosis and treatment of blood vessel diseases. Pressure measurements are also obtained to provide intra-catheter or intravascular pressure, such as within occlusion perfusion catheter, for the diagnosis and treatment within the vasculature.
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/K161263 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161263: OptoMonitor II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161263
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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