510(k) · Cleared
ClearedPressure Wire Sensor, Models 12003/12303, 12004/12304
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radi Medical Systems AB · DXO Transducer, Pressure, Catheter Tip
Cleared on Sep 24, 2002 as substantially equivalent to K002962 (Radi Medical Systems AB, 2000) and 1 other predicate after an 81-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Sep 24, 2002
- Review
- 81 days
- Class
- Class II
- Product code
- DXO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K972762 (1997). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK972762 Cardiometrics Flowire 300 and XT 300 Doppler Guide WiresCardio Metrics, Inc. · 1997 · Recalled
- This deviceK022187 Pressure Wire Sensor, Models 12003/12303, 12004/12304Radi Medical Systems AB · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972762 | Cardiometrics Flowire 300 and XT 300 Doppler Guide Wires | Cardio Metrics, Inc. | 1997 | 1 |
| 0 (this device) | K022187 | Pressure Wire Sensor, Models 12003/12303, 12004/12304 | Radi Medical Systems AB | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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? (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 |
|---|---|---|---|
| * | K002962 | Pressure Wire Sensor, Model 12003/12303Summary page 1…r Tip Pressure Transducer (870.2870) Thermodilution probe (870.1915) Predicate Device Names: PressureWireTMSensor (K002962) FloWire Doppler Guide wire (K972762) Device Description: The PressureWireTMSensor… | 2000 |
| * | K972762 | Cardiometrics Flowire 300 and XT 300 Doppler Guide WiresSummary page 1…Thermodilution probe (870.1915) Predicate Device Names: PressureWireTMSensor (K002962) FloWire Doppler Guide wire (K972762) Device Description: The PressureWireTMSensor consists of a pressure and temperature sensitive sensor mounted on a st… | 1997 |
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?
- 1 of the 2 ancestors has 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.
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 PressureWireTM Sensor is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the coronary and peripheral blood vessels
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022187 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022187: Pressure Wire Sensor, Models 12003/12303, 12004/12304.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022187
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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