510(k) · Cleared
ClearedFlowire and Flomap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardio Metrics, Inc. · DPW Flowmeter, Blood, Cardiovascular
Cleared on Mar 29, 1991 after a 116-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 of the 94 devices in its family, counting itself, have a Class I recall. 93 later devices descend from it.
- Decided
- Mar 29, 1991
- Review
- 116 days
- Class
- Class II
- Product code
- DPW
- Recalls
- None
- Predicates
- 0
93 later devices descend from it, 2 citing it directly. 7 of the 94 devices in this family, counting this one, have a Class I recall.
- This deviceK905411 Flowire and FlomapCardio Metrics, Inc. · 1991
- Descendant · cites it directly · 92 of its ownK965140 Cardiometrics Wavewire/Wavemap Pressure SystemCardio Metrics, Inc. · 1997
- Descendant · 2 generations on · 90 of its ownK021219 Smartwire/Smartmap Pressure SystemJomed, Inc. · 2002
- Descendant · 2 generations on · 85 of its ownK041134 Combomap Pressure and Flow SystemVolcano Therapeutics, Inc. · 2004
- Descendant · 3 generations on · 44 of its ownK070487 Smartwire Pressure Guide Wire, Model 66XXVolcano Corporation · 2007
- Descendant · 3 generations on · 40 of its ownK081625 Flowpicc StyletVasonova, Inc. · 2008
Showing 5 of 93 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 93 · See all- K965140Cardiometrics Wavewire/Wavemap Pressure SystemCardio Metrics, Inc. · 1997 · cites it directly92descendants
- K021219Smartwire/Smartmap Pressure SystemJomed, Inc. · 2002 · 2 generations on90descendants
- K041134Combomap Pressure and Flow SystemVolcano Therapeutics, Inc. · 2004 · 2 generations on85descendants
- K070487Smartwire Pressure Guide Wire, Model 66XXVolcano Corporation · 2007 · 3 generations on44descendants
- K081625Flowpicc StyletVasonova, Inc. · 2008 · 3 generations on40descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K905411 | Flowire and Flomap | Cardio Metrics, Inc. | 1991 | — |
| +1 | K965140 | Cardiometrics Wavewire/Wavemap Pressure System | Cardio Metrics, Inc. | 1997 | — |
| +2 | K021219 | Smartwire/Smartmap Pressure System | Jomed, Inc. | 2002 | — |
| +2 | K041134 | Combomap Pressure and Flow System | Volcano Therapeutics, Inc. | 2004 | — |
| +3 | K070487 | Smartwire Pressure Guide Wire, Model 66XX | Volcano Corporation | 2007 | — |
| +3 | K081625 | Flowpicc Stylet | Vasonova, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 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), 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 DPW device
- #1 K251114 FloPatch FP120score 13.7 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (93)
See all 932 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 3 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 · 5 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 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · 6 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 · 6 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 · 6 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 · 8 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?
- Of its descendants, K965140 (Cardio Metrics, Inc., 1997) has gone furthest, with 92 descendants of its own.
How does its category compare?
All DPW devicesDPW Flowmeter, Blood, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DPW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPW
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPW
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DPW
6in 2025
MAUDE reports naming product code DPW, 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 | — | 4 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 2 | — | 1 | 0 |
| 2011 | 4 | 89 | 0 | 1 |
| 2012 | 1 | — | 1 | 0 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 3 | 275 | 0 | 12 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 3 | 169 | 0 | 3 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 3 | 136 | 0 | 1 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 3 | 119 | 1 | 6 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K905411 · printed Nov 6, 2026
Cite this page
510(k) Report. “K905411: Flowire and Flomap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K905411
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026