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 Nov 24, 2020 as substantially equivalent to K193620 (Opsens, Inc., 2020) and 1 other predicate after a 55-day review. Its family tree reaches back 9 generations to 1982. 5 later devices descend from it.
- Decided
- Nov 24, 2020
- Review
- 55 days
- Class
- Class II
- Product code
- DXO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K823434 (1982). 20 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK823434 Mikro-Tip Catheter Pressure TransducerMillar Instruments, Inc. · 1982
- 5 generations between
- 3 generations backK142598 Opto Wire and OptoMonitor SystemOpsens, Inc. · 2015
- 2 generations backK192340 OptoMonitorOpsens, Inc. · 2019
- 1 generation backK193620 OptoMonitor 3Opsens, Inc. · 2020
- This deviceK202943 OptoMonitor 3Opsens, Inc. · 2020
- Descendant · cites it directly · 4 of its ownK213854 SavvyWireOpsens, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK241418 OptoMonitor 3Opsens, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK251367 OptoMonitor 3Opsens, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK252674 Solo Pace Fusion System (SOLOFUSE1)Solo Pace, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK240864 PacePro WireOpsens, Inc. · 2024
Show all 9 generations
- Root · 9 generations backK823434 Mikro-Tip Catheter Pressure TransducerMillar Instruments, Inc. · 1982
- 8 generations backK965140 Cardiometrics Wavewire/Wavemap Pressure SystemCardio Metrics, Inc. · 1997
- 7 generations backK021219 Smartwire/Smartmap Pressure SystemJomed, Inc. · 2002
- 6 generations backK070487 Smartwire Pressure Guide Wire, Model 66XXVolcano Corporation · 2007
- 5 generations backK100930 Primewire Prestiage Pressure Guide Wire, Models 8185, 8185J, 8300…Volcano Corporation · 2010
- 4 generations backK111395 Primewire Prestige PlusVolcano Corporation · 2011 · Recalled
- 3 generations backK142598 Opto Wire and OptoMonitor SystemOpsens, Inc. · 2015
- 2 generations backK192340 OptoMonitorOpsens, Inc. · 2019
- 1 generation backK193620 OptoMonitor 3Opsens, Inc. · 2020
- This deviceK202943 OptoMonitor 3Opsens, Inc. · 2020
Most influential descendants
Showing 5 of 5 · See all- K213854SavvyWireOpsens, Inc. · 2022 · cites it directly4descendants
- K241418OptoMonitor 3Opsens, Inc. · 2025 · 2 generations on1descendant
- K251367OptoMonitor 3Opsens, Inc. · 2026 · 3 generations on0descendants
- K252674Solo Pace Fusion System (SOLOFUSE1)Solo Pace, Inc. · 2026 · 2 generations on0descendants
- K240864PacePro WireOpsens, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K823434 | Mikro-Tip Catheter Pressure Transducer | Millar Instruments, Inc. | 1982 | — |
| −8 | K965140 | Cardiometrics Wavewire/Wavemap Pressure System | Cardio Metrics, Inc. | 1997 | — |
| −7 | K021219 | Smartwire/Smartmap Pressure System | Jomed, Inc. | 2002 | — |
| −6 | K070487 | Smartwire Pressure Guide Wire, Model 66XX | Volcano Corporation | 2007 | — |
| −5 | K100930 | Primewire Prestiage Pressure Guide Wire, Models 8185, 8185J, 8300, 8300J | Volcano Corporation | 2010 | — |
| −4 | K111395 | Primewire Prestige Plus | Volcano Corporation | 2011 | 1 |
| −3 | K142598 | Opto Wire and OptoMonitor System | Opsens, Inc. | 2015 | — |
| −2 | K192340 | OptoMonitor | Opsens, Inc. | 2019 | — |
| −1 | K193620 | OptoMonitor 3 | Opsens, Inc. | 2020 | — |
| 0 (this device) | K202943 | OptoMonitor 3 | Opsens, Inc. | 2020 | — |
| +1 | K213854 | SavvyWire | Opsens, Inc. | 2022 | — |
| +2 | K241418 | OptoMonitor 3 | Opsens, Inc. | 2025 | — |
| +3 | K251367 | OptoMonitor 3 | Opsens, Inc. | 2026 | — |
| +2 | K252674 | Solo Pace Fusion System (SOLOFUSE1) | Solo Pace, Inc. | 2026 | — |
| +2 | K240864 | PacePro Wire | Opsens, Inc. | 2024 | — |
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 |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K193620 | OptoMonitor 3Summary page 4…on name: Transducer, pressure, catheter tip (870.2870) Regulatory Class: II Product Code: DXO 3. PREDICATE DEVICE OptoMonitor 3 System cleared via K193620 (cleared on 06/18/2020). This predicate has not been subject to a design-related recall. No reference devices were used in this s… | 2020 |
| * | K192340 | OptoMonitorSummary page 5…wireless function. Therefore, the proposed device, OptoMonitor 3, meets substantial equivalence requirements with regards to the legally marketed predicate OptoMonitor (K192340 cleared on 12/12/2019). For detailed comparison, refer to the Substantial Equivalence table on the following pages.… | 2019 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213854 | SavvyWire | 2022 | 4 |
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 38 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K213854 (Opsens, Inc., 2022) has gone furthest, with 4 descendants of its own.
How does its category compare?
All DXO devicesDXO Transducer, Pressure, Catheter Tip: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
To measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures.
Blood pressure measurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel desease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202943 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202943: 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/K202943
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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