510(k) · Cleared
ClearedCombowire Pressure and Flow Guide Wire, Combotip Pressure and Flow Guide Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Volcano Therapeutics, Inc. · DQX Wire, Guide, Catheter
Cleared on Nov 24, 2004 as substantially equivalent to K021219 (Jomed, Inc., 2002) and 4 other predicates after a 23-day review. Its family tree reaches back 3 generations to 1982. 1 of the 44 devices in its family, counting itself, has a Class I recall. 29 later devices descend from it.
- Decided
- Nov 24, 2004
- Review
- 23 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K823434 (1982). 14 ancestors in all. 29 later devices descend from it, 1 citing it directly. 1 of the 44 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK823434 Mikro-Tip Catheter Pressure TransducerMillar Instruments, Inc. · 1982
- 2 generations backK965140 Cardiometrics Wavewire/Wavemap Pressure SystemCardio Metrics, Inc. · 1997
- 1 generation backK021219 Smartwire/Smartmap Pressure SystemJomed, Inc. · 2002
- This deviceK042996 Combowire Pressure and Flow Guide Wire, Combotip Pressure and Flow…Volcano Therapeutics, Inc. · 2004
- Descendant · cites it directly · 28 of its ownK071554 Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation · 2008 · Recalled
- Descendant · 2 generations on · 25 of its ownK082229 S5/S5I Series Intravascular Imaging and Pressure System, Combomap…Volcano Corporation · 2008 · Recalled
- Descendant · 3 generations on · 24 of its ownK111706 Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · Recalled
- Descendant · 4 generations on · 21 of its ownK123898 Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation · 2013 · Recalled
- Descendant · 5 generations on · 18 of its ownK133323 Volcano Ifr ModalityVolcano Corporation · 2014
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K172258 Novasight Hybrid System2 generations on · 2018
Most influential descendants
Showing 5 of 29 · See all- K071554Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation · 2008 · cites it directly28descendants
- K082229S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow SystemVolcano Corporation · 2008 · 2 generations on25descendants
- K111706Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · 3 generations on24descendants
- K123898Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation · 2013 · 4 generations on21descendants
- K133323Volcano Ifr ModalityVolcano Corporation · 2014 · 5 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K823434 | Mikro-Tip Catheter Pressure Transducer | Millar Instruments, Inc. | 1982 | — |
| −2 | K965140 | Cardiometrics Wavewire/Wavemap Pressure System | Cardio Metrics, Inc. | 1997 | — |
| −1 | K021219 | Smartwire/Smartmap Pressure System | Jomed, Inc. | 2002 | — |
| 0 (this device) | K042996 | Combowire Pressure and Flow Guide Wire, Combotip Pressure and Flow Guide Wire | Volcano Therapeutics, Inc. | 2004 | — |
| +1 | K071554 | Volcano S5/S5I Intravascular Imaging and Pressure System | Volcano Corporation | 2008 | 2 |
| +2 | K082229 | S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and… | Volcano Corporation | 2008 | 3 |
| +3 | K111706 | Volcano S5IINTRAVASCULAR Imaging and Pressure System | Volcano Corporation | 2011 | 1 |
| +4 | K123898 | Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure System | Volcano Corporation | 2013 | 10 |
| +5 | K133323 | Volcano Ifr Modality | Volcano Corporation | 2014 | — |
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 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K021219 | Smartwire/Smartmap Pressure SystemSummary page 1…Current Wires Wires 510(k) Catalog Product Clearance Numbers Name SmartWire K021219 6400, 6400J, BrightWire 6403, 6403J, (name is used… | 2002 |
| * | K905411 | Flowire and FlomapSummary page 1…European 70,70J countries due 7403, 7403J to trademark FoIre K905411, 1400, 1400J, K912776, 1401, 1401J, K921563… | 1991 |
| * | K912776 | Cardiometrics Flowire/Flomap Doppler UltrasoundSummary page 1…untries due 7403, 7403J to trademark FoIre K905411, 1400, 1400J, K912776, 1401, 1401J, K921563, 1403, 1403J, K972762… | 1992 |
| * | K921563 | Cardiometrics Flowire/Flomap SystemSummary page 1…trademark FoIre K905411, 1400, 1400J, K912776, 1401, 1401J, K921563, 1403, 1403J, K972762 1404, 1404J, ___… | 1992 |
| * | K972762 | Cardiometrics Flowire 300 and XT 300 Doppler Guide WiresSummary page 1…00, 1400J, K912776, 1401, 1401J, K921563, 1403, 1403J, K972762 1404, 1404J, ___ ___ ___ __ ___ ___ ___ 1413, 1413J Volcano Therape… | 1997 |
What descends from it? (29)
See all 291 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071554 | Volcano S5/S5I Intravascular Imaging and Pressure System | 2008 | 28 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 2 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K071554 (Volcano Corporation, 2008) has gone furthest, with 28 descendants of its own.
- 5 other devices also cite its predicate K021219.
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?
ComboWireTM and ComboTipTM Pressure/Flow Guide Wire is indicated for use to measure simultaneous pressure and blood flow velocities in blood vessels, including coronary and peripheral vessels, during diagnostic angiography and/or interventional procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042996 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042996: Combowire Pressure and Flow Guide Wire, Combotip Pressure and Flow Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042996
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