510(k) · Cleared
Recalled · 2009Cardiometrics Flowire 300 and XT 300 Doppler Guide Wires
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardio Metrics, Inc. · DQX Wire, Guide, Catheter
Cleared on Oct 14, 1997 after an 82-day review. The FDA summary names its predicate without a number. 1 of the 32 devices in its family, counting itself, has a Class I recall. 31 later devices descend from it. It has been recalled once.
- Decided
- Oct 14, 1997
- Review
- 82 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 1
- Predicates
- 0
31 later devices descend from it, 2 citing it directly. 1 of the 32 devices in this family, counting this one, has a Class I recall.
- This deviceK972762 Cardiometrics Flowire 300 and XT 300 Doppler Guide WiresCardio Metrics, Inc. · 1997
- Descendant · cites it directly · 29 of its ownK042996 Combowire Pressure and Flow Guide Wire, Combotip Pressure and Flow…Volcano Therapeutics, Inc. · 2004
- Descendant · 2 generations on · 28 of its ownK071554 Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation · 2008 · Recalled
- Descendant · 3 generations on · 25 of its ownK082229 S5/S5I Series Intravascular Imaging and Pressure System, Combomap…Volcano Corporation · 2008 · Recalled
- Descendant · 4 generations on · 24 of its ownK111706 Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · Recalled
- Descendant · 5 generations on · 21 of its ownK123898 Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation · 2013 · Recalled
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K172258 Novasight Hybrid System3 generations on · 2018
Most influential descendants
Showing 5 of 31 · See all- K042996Combowire Pressure and Flow Guide Wire, Combotip Pressure and Flow Guide WireVolcano Therapeutics, Inc. · 2004 · cites it directly29descendants
- K071554Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation · 2008 · 2 generations on28descendants
- K082229S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow SystemVolcano Corporation · 2008 · 3 generations on25descendants
- K111706Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · 4 generations on24descendants
- K123898Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation · 2013 · 5 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972762 | Cardiometrics Flowire 300 and XT 300 Doppler Guide Wires | Cardio Metrics, Inc. | 1997 | — |
| +1 | K042996 | Combowire Pressure and Flow Guide Wire, Combotip Pressure and Flow Guide Wire | Volcano Therapeutics, Inc. | 2004 | — |
| +2 | K071554 | Volcano S5/S5I Intravascular Imaging and Pressure System | Volcano Corporation | 2008 | 2 |
| +3 | K082229 | S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and… | Volcano Corporation | 2008 | 3 |
| +4 | K111706 | Volcano S5IINTRAVASCULAR Imaging and Pressure System | Volcano Corporation | 2011 | 1 |
| +5 | K123898 | Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure System | Volcano Corporation | 2013 | 10 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 1 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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.
1 device in this family has a Class I recall. 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 DQX device
- #1 K213854 SavvyWirescore 15.7 · 10 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 |
|---|---|---|---|
| * | — | Cardiometrics FloWire Doppler Guide Wire with CINCH® extension Named without a submission number | |
| * | — | Cardiometrics FloWire XT Doppler Guide Wire with CINCH® extension Named without a submission number |
What descends from it? (31)
See all 312 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 6, 2009 | Not classified | Z-0935-2012 | Employee error | Reports of no signal displayed on the monitor when FloWire Doppler Guide wires were connected to the Combomap. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K172258Novasight Hybrid SystemConavi Medical, Inc. · 2018 · 3 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K042996 (Volcano Therapeutics, Inc., 2004) has gone furthest, with 29 descendants of its own.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQX
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQX
177in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQX
3in 2024
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · DQX
2,178in 2025
MAUDE reports naming product code DQX, 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 | 14 | 85 | 12 | 760 |
| 2008 | 19 | 87 | 7 | 715 |
| 2009 | 18 | 87 | 49 | 687 |
| 2010 | 21 | 63 | 34 | 987 |
| 2011 | 18 | 43 | 3 | 1,311 |
| 2012 | 20 | 62 | 5 | 1,337 |
| 2013 | 18 | 119 | 7 (4) | 1,474 |
| 2014 | 18 | 103 | 0 | 1,323 |
| 2015 | 15 | 112 | 1 | 1,323 |
| 2016 | 14 | 179 | 2 (2) | 1,466 |
| 2017 | 19 | 85 | 17 | 1,524 |
| 2018 | 19 | 114 | 9 | 1,737 |
| 2019 | 13 | 173 | 2 | 1,679 |
| 2020 | 14 | 106 | 1 (1) | 1,536 |
| 2021 | 6 | 161 | 0 | 1,713 |
| 2022 | 15 | 212 | 0 | 1,647 |
| 2023 | 10 | 136 | 0 | 2,068 |
| 2024 | 11 | 134 | 3 | 2,210 |
| 2025 | 10 | 177 | 0 | 2,178 |
| 2026 | 12 | 145 | 4 (1) | — |
What is it indicated for?
The Cardiometrics FloWire 300 Doppler Guide Wire and the Cardiometrics FloWire XT 300 Doppler Guide Wires are intended for use in all blood vessels, including both coronary and peripheral arteries, to measure blood flow velocities during diagnostic angiography and/or interventional procedures. The FloWire may be used to guide the positioning of a balloon dilatation catheter, as well as other interventional devices. Blood flow velocity measurements are obtained to provide hemodynamic information for the diagnosis and treatment of coronary or peripheral artery disease.
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/K972762 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972762: Cardiometrics Flowire 300 and XT 300 Doppler Guide Wires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972762
Report an extraction error
Are you the manufacturer?
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