510(k) · Cleared
ClearedOptoMonitor 3
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 Jan 16, 2026 as substantially equivalent to K241418 (Opsens, Inc., 2025) after a 260-day review. Its family tree reaches back 12 generations to 1982.
- Decided
- Jan 16, 2026
- Review
- 260 days
- Class
- Class II
- Product code
- DXO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K823434 (1982). 40 ancestors in all, the oldest K800298 (1980). No later device cites it as a predicate yet.
- Root · 12 generations backK823434 Mikro-Tip Catheter Pressure TransducerMillar Instruments, Inc. · 1982
- 8 generations between
- 3 generations backK202943 OptoMonitor 3Opsens, Inc. · 2020
- 2 generations backK213854 SavvyWireOpsens, Inc. · 2022
- 1 generation backK241418 OptoMonitor 3Opsens, Inc. · 2025
- This deviceK251367 OptoMonitor 3Opsens, Inc. · 2026
Show all 12 generations
- Root · 12 generations backK823434 Mikro-Tip Catheter Pressure TransducerMillar Instruments, Inc. · 1982
- 11 generations backK965140 Cardiometrics Wavewire/Wavemap Pressure SystemCardio Metrics, Inc. · 1997
- 10 generations backK021219 Smartwire/Smartmap Pressure SystemJomed, Inc. · 2002
- 9 generations backK070487 Smartwire Pressure Guide Wire, Model 66XXVolcano Corporation · 2007
- 8 generations backK100930 Primewire Prestiage Pressure Guide Wire, Models 8185, 8185J, 8300…Volcano Corporation · 2010
- 7 generations backK111395 Primewire Prestige PlusVolcano Corporation · 2011 · Recalled
- 6 generations backK142598 Opto Wire and OptoMonitor SystemOpsens, Inc. · 2015
- 5 generations backK192340 OptoMonitorOpsens, Inc. · 2019
- 4 generations backK193620 OptoMonitor 3Opsens, Inc. · 2020
- 3 generations backK202943 OptoMonitor 3Opsens, Inc. · 2020
- 2 generations backK213854 SavvyWireOpsens, Inc. · 2022
- 1 generation backK241418 OptoMonitor 3Opsens, Inc. · 2025
- This deviceK251367 OptoMonitor 3Opsens, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K823434 | Mikro-Tip Catheter Pressure Transducer | Millar Instruments, Inc. | 1982 | — |
| −11 | K965140 | Cardiometrics Wavewire/Wavemap Pressure System | Cardio Metrics, Inc. | 1997 | — |
| −10 | K021219 | Smartwire/Smartmap Pressure System | Jomed, Inc. | 2002 | — |
| −9 | K070487 | Smartwire Pressure Guide Wire, Model 66XX | Volcano Corporation | 2007 | — |
| −8 | K100930 | Primewire Prestiage Pressure Guide Wire, Models 8185, 8185J, 8300, 8300J | Volcano Corporation | 2010 | — |
| −7 | K111395 | Primewire Prestige Plus | Volcano Corporation | 2011 | 1 |
| −6 | K142598 | Opto Wire and OptoMonitor System | Opsens, Inc. | 2015 | — |
| −5 | K192340 | OptoMonitor | Opsens, Inc. | 2019 | — |
| −4 | K193620 | OptoMonitor 3 | Opsens, Inc. | 2020 | — |
| −3 | K202943 | OptoMonitor 3 | Opsens, Inc. | 2020 | — |
| −2 | K213854 | SavvyWire | Opsens, Inc. | 2022 | — |
| −1 | K241418 | OptoMonitor 3 | Opsens, Inc. | 2025 | — |
| 0 (this device) | K251367 | OptoMonitor 3 | Opsens, 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 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? (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 |
|---|---|---|---|
| * | K241418 | OptoMonitor 3Summary page 5…er Regulatory Class: II Product Code: DXO PREDICATE DEVICE The proposed OptoMonitor 3 is substantially equivalent to the OptoMonitor 3 cleared in K241418 on 02/12/2025 [Predicate]. The predicate device has not been subject to a design-related recall. DEVICE DESCRIPTION The OptoMo… | 2025 |
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 5 companies; a new generation was cleared every 3.1 years on median.
- 5 of the 40 ancestors have a recall of any class.
How does its category compare?
All DXO devicesDXO Transducer, Pressure, Catheter Tip: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 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/K251367 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251367: OptoMonitor 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251367
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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