510(k) · Cleared
ClearedSmartwire/Smartmap Pressure System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jomed, Inc. · DQX Wire, Guide, Catheter
Cleared on May 17, 2002 as substantially equivalent to K965140 (Cardio Metrics, Inc., 1997) after a 30-day review. Its family tree reaches back 2 generations to 1982. 7 of the 103 devices in its family, counting itself, have a Class I recall. 90 later devices descend from it.
- Decided
- May 17, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K823434 (1982). 12 ancestors in all. 90 later devices descend from it, 6 citing it directly. 7 of the 103 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK823434 Mikro-Tip Catheter Pressure TransducerMillar Instruments, Inc. · 1982
- 1 generation backK965140 Cardiometrics Wavewire/Wavemap Pressure SystemCardio Metrics, Inc. · 1997
- This deviceK021219 Smartwire/Smartmap Pressure SystemJomed, Inc. · 2002
- Descendant · cites it directly · 85 of its ownK041134 Combomap Pressure and Flow SystemVolcano Therapeutics, Inc. · 2004
- Descendant · cites it directly · 44 of its ownK070487 Smartwire Pressure Guide Wire, Model 66XXVolcano Corporation · 2007
- Descendant · 2 generations on · 40 of its ownK081625 Flowpicc StyletVasonova, Inc. · 2008
- Descendant · 2 generations on · 39 of its ownK081626 Flowpicc ConsoleVasonova, Inc. · 2008
- Descendant · 3 generations on · 38 of its ownK091324 Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning…C.R. Bard, Inc. · 2009 · Recalled
Showing 5 of 90 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 90 · See all- K041134Combomap Pressure and Flow SystemVolcano Therapeutics, Inc. · 2004 · cites it directly85descendants
- K070487Smartwire Pressure Guide Wire, Model 66XXVolcano Corporation · 2007 · cites it directly44descendants
- K081625Flowpicc StyletVasonova, Inc. · 2008 · 2 generations on40descendants
- K081626Flowpicc ConsoleVasonova, Inc. · 2008 · 2 generations on39descendants
- K091324Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System StyletC.R. Bard, Inc. · 2009 · 3 generations on38descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K823434 | Mikro-Tip Catheter Pressure Transducer | Millar Instruments, Inc. | 1982 | — |
| −1 | K965140 | Cardiometrics Wavewire/Wavemap Pressure System | Cardio Metrics, Inc. | 1997 | — |
| 0 (this device) | K021219 | Smartwire/Smartmap Pressure System | Jomed, Inc. | 2002 | — |
| +1 | K041134 | Combomap Pressure and Flow System | Volcano Therapeutics, Inc. | 2004 | — |
| +1 | K070487 | Smartwire Pressure Guide Wire, Model 66XX | Volcano Corporation | 2007 | — |
| +2 | K081625 | Flowpicc Stylet | Vasonova, Inc. | 2008 | — |
| +2 | K081626 | Flowpicc Console | Vasonova, Inc. | 2008 | — |
| +3 | K091324 | Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet | C.R. Bard, Inc. | 2009 | 11 |
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 |
|---|---|---|
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 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 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? (1)
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 |
|---|---|---|---|
| * | K965140 | Cardiometrics Wavewire/Wavemap Pressure SystemSummary page 1…tip pressure transducer Vessel occlusion transducer Patient transducer and electrical cable (including connector) Predicate Device: = WaveWire/WaveMap Pressure System, K965140 Device Description: The Jometrics SmartWire/SmartMap Pressure System consists of the SmartWire and the SmartMap. Additionally,… | 1997 |
What descends from it? (90)
See all 906 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041134 | Combomap Pressure and Flow System | 2004 | 85 |
| K070487 | Smartwire Pressure Guide Wire, Model 66XX | 2007 | 44 |
| K042996 | Combowire Pressure and Flow Guide Wire, Combotip Pressure and Flow Guide Wire | 2004 | 29 |
| 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 |
| K100930 | Primewire Prestiage Pressure Guide Wire, Models 8185, 8185J, 8300, 8300J | 2010 | 14 |
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 · 4 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 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · 5 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 · 5 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 · 5 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 · 7 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 20 years and passes through 3 companies; a new generation was cleared every 14.7 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K041134 (Volcano Therapeutics, Inc., 2004) has gone furthest, with 85 descendants of its own.
- 4 other devices also cite its predicate K965140.
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 SmartWire/SmartMap Pressure System is indicated for use in all blood vessels, including coronary and peripheral arteries to measures blood pressure 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/K021219 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021219: Smartwire/Smartmap Pressure System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021219
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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