510(k) · Cleared
ClearedCombomap Pressure and Flow System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Volcano Therapeutics, Inc. · OBJ Catheter, Ultrasound, Intravascular
Cleared on Jun 2, 2004 as substantially equivalent to K021219 (Jomed, Inc., 2002) and 2 other predicates after a 33-day review. Its family tree reaches back 3 generations to 1982. 7 of the 99 devices in its family, counting itself, have a Class I recall. 85 later devices descend from it.
- Decided
- Jun 2, 2004
- Review
- 33 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K823434 (1982). 13 ancestors in all. 85 later devices descend from it, 8 citing it directly. 7 of the 99 devices in this family, counting this one, have 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 deviceK041134 Combomap Pressure and Flow SystemVolcano Therapeutics, Inc. · 2004
- Descendant · cites it directly · 40 of its ownK081625 Flowpicc StyletVasonova, Inc. · 2008
- Descendant · cites it directly · 39 of its ownK081626 Flowpicc ConsoleVasonova, Inc. · 2008
- Descendant · 2 generations on · 38 of its ownK091324 Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning…C.R. Bard, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 34 of its ownK093775 Evguide Tip Location SystemRomedex International Srl · 2010
- Descendant · cites it directly · 28 of its ownK071554 Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation · 2008 · Recalled
Showing 5 of 85 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 85 · See all- K081625Flowpicc StyletVasonova, Inc. · 2008 · cites it directly40descendants
- K081626Flowpicc ConsoleVasonova, Inc. · 2008 · cites it directly39descendants
- K091324Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System StyletC.R. Bard, Inc. · 2009 · 2 generations on38descendants
- K093775Evguide Tip Location SystemRomedex International Srl · 2010 · 3 generations on34descendants
- K071554Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation · 2008 · cites it directly28descendants
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) | K041134 | Combomap Pressure and Flow System | Volcano Therapeutics, Inc. | 2004 | — |
| +1 | K081625 | Flowpicc Stylet | Vasonova, Inc. | 2008 | — |
| +1 | K081626 | Flowpicc Console | Vasonova, Inc. | 2008 | — |
| +2 | K091324 | Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet | C.R. Bard, Inc. | 2009 | 11 |
| +3 | K093775 | Evguide Tip Location System | Romedex International Srl | 2010 | — |
| +1 | K071554 | Volcano S5/S5I Intravascular Imaging and Pressure System | Volcano Corporation | 2008 | 2 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 1 |
| 2013 | 9 | 2 |
| 2014 | 5 | 0 |
| 2015 | 9 | 0 |
| 2016 | 6 | 3 |
| 2017 | 6 | 0 |
| 2018 | 4 | 1 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 6 | 0 |
| 2026 | 5 | 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.
7 devices in this family have 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 OBJ device
- #1 K242893 VERAFEYE System VERAFEYE Imaging Catheter &…score 23.8 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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…d Pressure Computer II 870.2900 - Patient Transducer and Electrical Cable II Predicate Device: SmartMapR Pressure System K021219 WaveMapR Pressure System K965140 F1oMapR Doppler Flow System K921563 Volcano Therapeutics Inc. purchased… | 2002 |
| * | K965140 | Cardiometrics Wavewire/Wavemap Pressure SystemSummary page 1…870.2900 - Patient Transducer and Electrical Cable II Predicate Device: SmartMapR Pressure System K021219 WaveMapR Pressure System K965140 F1oMapR Doppler Flow System K921563 Volcano Therapeutics Inc. purchased the assets of JOMED Inc. who had previously pu… | 1997 |
| * | K921563 | Cardiometrics Flowire/Flomap SystemSummary page 1…ical Cable II Predicate Device: SmartMapR Pressure System K021219 WaveMapR Pressure System K965140 F1oMapR Doppler Flow System K921563 Volcano Therapeutics Inc. purchased the assets of JOMED Inc. who had previously purchased Cardiometrics, Inc. under which K02121… | 1992 |
What descends from it? (85)
See all 858 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081625 | Flowpicc Stylet | 2008 | 40 |
| K081626 | Flowpicc Console | 2008 | 39 |
| K071554 | Volcano S5/S5I Intravascular Imaging and Pressure System | 2008 | 28 |
| K082229 | S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow System | 2008 | 25 |
| K142598 | Opto Wire and OptoMonitor System | 2015 | 12 |
| K192340 | OptoMonitor | 2019 | 7 |
| K161263 | OptoMonitor II | 2016 | 0 |
| K123792 | Horizon Xvu (FFR) | 2013 | 0 |
Has anything in its family been recalled? (7 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
- K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K160925VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.) · 2016 · 6 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
Nearest 5 of 7; all are on the web page.
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.
- None of the 13 ancestors has a recall.
- Of its descendants, K081625 (Vasonova, Inc., 2008) has gone furthest, with 40 descendants of its own.
- 5 other devices also cite its predicate K021219.
How does its category compare?
All OBJ devicesOBJ Catheter, Ultrasound, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OBJ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OBJ
35in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OBJ
2in 2020
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OBJ
791in 2025
MAUDE reports naming product code OBJ, 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 | 3 | 74 | 0 | 0 |
| 2008 | 6 | 100 | 0 | 6 |
| 2009 | 3 | 108 | 0 | 22 |
| 2010 | 1 | — | 0 | 39 |
| 2011 | 4 | 109 | 0 | 47 |
| 2012 | 3 | 136 | 0 | 53 |
| 2013 | 4 | 96 | 0 | 328 |
| 2014 | 3 | 30 | 0 | 609 |
| 2015 | 4 | 131 | 2 | 401 |
| 2016 | 4 | 94 | 0 | 515 |
| 2017 | 6 | 45 | 2 | 524 |
| 2018 | 2 | — | 2 | 542 |
| 2019 | 1 | — | 0 | 237 |
| 2020 | 4 | 135 | 2 | 288 |
| 2021 | 3 | 29 | 0 | 353 |
| 2022 | 3 | 63 | 0 | 473 |
| 2023 | 3 | 63 | 0 | 697 |
| 2024 | 3 | 131 | 0 | 1,154 |
| 2025 | 7 | 35 | 0 | 791 |
| 2026 | 4 | 81 | 1 (1) | — |
What is it indicated for?
ComboMapTM Pressure and Flow System is a multi-mode system intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure and/or blood flow velocities during diagnostic angiography and/or interventional procedures.
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/K041134 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041134: Combomap Pressure and Flow System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041134
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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