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 Feb 12, 2025 as substantially equivalent to K213854 (Opsens, Inc., 2022) after a 268-day review. Its family tree reaches back 11 generations to 1982. 1 later device descends from it.
- Decided
- Feb 12, 2025
- Review
- 268 days
- Class
- Class II
- Product code
- DXO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K823434 (1982). 39 ancestors in all, the oldest K800298 (1980). 1 later device descends from it, 1 citing it directly.
- 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 deviceK241418 OptoMonitor 3Opsens, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK251367 OptoMonitor 3Opsens, 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 deviceK241418 OptoMonitor 3Opsens, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251367OptoMonitor 3Opsens, Inc. · 2026 · cites it directly0descendants
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) | K241418 | OptoMonitor 3 | Opsens, Inc. | 2025 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 K251367 OptoMonitor 3score 14.0 · 12 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…ulatory Class: II Product Code: DXO PREDICATE DEVICE The proposed OptoMonitor 3 is substantially equivalent to the Opsens existing OptoMonitor 3 cleared in K213854 on 09/14/2022 [Predicate]. The predicate device has not been subject to a design-related recall. DEVICE DESCRIPTION The propos… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251367 | OptoMonitor 3 | 2026 | 0 |
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 43 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 5 of the 39 ancestors have a recall of any class.
- Of its descendants, K251367 (Opsens, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K213854.
How does its category compare?
All DXO devicesDXO Transducer, Pressure, Catheter Tip: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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/K241418 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241418: OptoMonitor 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241418
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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