510(k) · Cleared

Cleared

Cardiometrics Wavewire/Wavemap Pressure System

K965140510(k) TraditionalCleared Aug 18, 1997238-day reviewClass II21 CFR 870.1330

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cardio Metrics, Inc. · DQX Wire, Guide, Catheter

Cleared on Aug 18, 1997 as substantially equivalent to K905411 (Cardio Metrics, Inc., 1991) and 10 other predicates after a 238-day review. Its family tree reaches back 1 generation to 1982. 7 of the 104 devices in its family, counting itself, have a Class I recall. 92 later devices descend from it.

Decided: Aug 18, 1997
Review: 238 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 11

Its longest line of descent runs back 1 generation to K823434 (1982). 11 ancestors in all. 92 later devices descend from it, 5 citing it directly. 7 of the 104 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK823434 Mikro-Tip Catheter Pressure TransducerMillar Instruments, Inc. · 1982
This deviceK965140 Cardiometrics Wavewire/Wavemap Pressure SystemCardio Metrics, Inc. · 1997
Descendant · cites it directly · 90 of its ownK021219 Smartwire/Smartmap Pressure SystemJomed, Inc. · 2002
Descendant · cites it directly · 85 of its ownK041134 Combomap Pressure and Flow SystemVolcano Therapeutics, Inc. · 2004
Descendant · 2 generations on · 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

Showing 5 of 92 descendants. See all descendants

Descendants cleared per year

1998high 9 (2013) · low 0 (1999)2026

Class I recalls in this family

K172258 Novasight Hybrid System2 generations on · 2018
K122545 CG+ Arrow Picc Powered by Arrow VPS Stylet4 generations on · 2012
K132133 CG+ Arrow Jacc Powered by Arrow VPS Stylet4 generations on · 2013
K130876 CG+ Arrow Picc Powered by Arrow VPS Stylet5 generations on · 2013

Most influential descendants

Showing 5 of 92 · See all

K021219Smartwire/Smartmap Pressure SystemJomed, Inc. · 2002 · cites it directly90descendants
K041134Combomap Pressure and Flow SystemVolcano Therapeutics, Inc. · 2004 · cites it directly85descendants
K070487Smartwire Pressure Guide Wire, Model 66XXVolcano Corporation · 2007 · 2 generations on44descendants
K081625Flowpicc StyletVasonova, Inc. · 2008 · 2 generations on40descendants
K081626Flowpicc ConsoleVasonova, Inc. · 2008 · 2 generations on39descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K823434	Mikro-Tip Catheter Pressure Transducer	Millar Instruments, Inc.	1982	—
0 (this device)	K965140	Cardiometrics Wavewire/Wavemap Pressure System	Cardio Metrics, Inc.	1997	—
+1	K021219	Smartwire/Smartmap Pressure System	Jomed, Inc.	2002	—
+1	K041134	Combomap Pressure and Flow System	Volcano Therapeutics, Inc.	2004	—
+2	K070487	Smartwire Pressure Guide Wire, Model 66XX	Volcano Corporation	2007	—
+2	K081625	Flowpicc Stylet	Vasonova, Inc.	2008	—
+2	K081626	Flowpicc Console	Vasonova, Inc.	2008	—

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
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

FIG. 1 — Lineage of K965140, 1982–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (11)

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	Applicant	Decided	Recalls
*	K905411	Flowire and Flomap Summary page 3 …sure System is substantially equivalent in design to two currently marketed Cardiometrics products, the FloWire®/FloMap® Doppler Ultrasound Instrument, accession numbers K905411, K912776, K921563, K932536, K941485, K943022, and K955551 and the AccuTrac™ Intravascular Guide Wire, accession numbers K952562 a…	Cardio Metrics, Inc.	1991	—
*	K912776	Cardiometrics Flowire/Flomap Doppler Ultrasound Summary page 3 …em is substantially equivalent in design to two currently marketed Cardiometrics products, the FloWire®/FloMap® Doppler Ultrasound Instrument, accession numbers K905411, K912776, K921563, K932536, K941485, K943022, and K955551 and the AccuTrac™ Intravascular Guide Wire, accession numbers K952562 and K96177…	Cardio Metrics, Inc.	1992	—
*	K921563	Cardiometrics Flowire/Flomap System Summary page 3 …stantially equivalent in design to two currently marketed Cardiometrics products, the FloWire®/FloMap® Doppler Ultrasound Instrument, accession numbers K905411, K912776, K921563, K932536, K941485, K943022, and K955551 and the AccuTrac™ Intravascular Guide Wire, accession numbers K952562 and K961777. In add…	Cardio Metrics, Inc.	1992	—
*	K932536	Cardiometrics Flowire & Flomap Summary page 3 …y equivalent in design to two currently marketed Cardiometrics products, the FloWire®/FloMap® Doppler Ultrasound Instrument, accession numbers K905411, K912776, K921563, K932536, K941485, K943022, and K955551 and the AccuTrac™ Intravascular Guide Wire, accession numbers K952562 and K961777. In addition, th…	Cardio Metrics, Inc.	1993	—
*	K941485	Cardiometrics Flowire Doppler Guide Wires Summary page 3 …ent in design to two currently marketed Cardiometrics products, the FloWire®/FloMap® Doppler Ultrasound Instrument, accession numbers K905411, K912776, K921563, K932536, K941485, K943022, and K955551 and the AccuTrac™ Intravascular Guide Wire, accession numbers K952562 and K961777. In addition, the WaveWir…	Cardio Metrics, Inc.	1994	—
*	K943022	Cardiometrics Flowire Doppler Guide Wire Summary page 3 …sign to two currently marketed Cardiometrics products, the FloWire®/FloMap® Doppler Ultrasound Instrument, accession numbers K905411, K912776, K921563, K932536, K941485, K943022, and K955551 and the AccuTrac™ Intravascular Guide Wire, accession numbers K952562 and K961777. In addition, the WaveWire/WaveMap…	Cardio Metrics, Inc.	1994	—
*	K955551	CARDI0METRICS Flow Wire XT Doppler Guide Model 1403, 1404 Summary page 3 …urrently marketed Cardiometrics products, the FloWire®/FloMap® Doppler Ultrasound Instrument, accession numbers K905411, K912776, K921563, K932536, K941485, K943022, and K955551 and the AccuTrac™ Intravascular Guide Wire, accession numbers K952562 and K961777. In addition, the WaveWire/WaveMap Pressure Sys…	Cardio Metrics, Inc.	1996	—
*	K952562	Cardiometrics Accutrac Intravascular Guide Wire Summary page 3 …Ultrasound Instrument, accession numbers K905411, K912776, K921563, K932536, K941485, K943022, and K955551 and the AccuTrac™ Intravascular Guide Wire, accession numbers K952562 and K961777. In addition, the WaveWire/WaveMap Pressure System’s intended use, to measure and monitor intravascular blood pressur…	Cardio Metrics, Inc.	1995	—
*	K961777	Accutrac XT Intravascular Guide Wire (Floppy) Model 2403/(Flex) Model 2404 Summary page 3 …Instrument, accession numbers K905411, K912776, K921563, K932536, K941485, K943022, and K955551 and the AccuTrac™ Intravascular Guide Wire, accession numbers K952562 and K961777. In addition, the WaveWire/WaveMap Pressure System’s intended use, to measure and monitor intravascular blood pressure, is substa…	Cardio Metrics, Inc.	1996	—
*	K862673	Model 6615 Floscan Doppler Diagnostic Catheter Summary page 3 …’s intended use, to measure and monitor intravascular blood pressure, is substantially equivalent to the Medtronic Floscan® Doppler Diagnostic Catheter, accession number K862673, and the Millar Mikro-Tip® Catheter Pressure Transducer, accession number K823434. Biocompatibility Evaluations The matenals us…	Medtronic Vascular	1986	—
*	K823434	Mikro-Tip Catheter Pressure Transducer Summary page 3 …ally equivalent to the Medtronic Floscan® Doppler Diagnostic Catheter, accession number K862673, and the Millar Mikro-Tip® Catheter Pressure Transducer, accession number K823434. Biocompatibility Evaluations The matenals used in the WaveWire Pressure Wire are the same as those used in the FloWire Doppler…	Millar Instruments, Inc.	1982	—

Also cleared against K905411: 1 other device →

What descends from it? (92)

See all 92

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K021219	Smartwire/Smartmap Pressure System	Jomed, Inc.	2002	90
K041134	Combomap Pressure and Flow System	Volcano Therapeutics, Inc.	2004	85
K071554	Volcano S5/S5I Intravascular Imaging and Pressure System	Volcano Corporation	2008	28
K082229	S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow System	Volcano Corporation	2008	25
K974241	Scimed Informer Pressure Wire System	Scimed Life Systems, Inc.	1998	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 · 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?

None of the 11 ancestors has a recall.
Of its descendants, K021219 (Jomed, Inc., 2002) has gone furthest, with 90 descendants of its own.
1 other device also cites its predicate K905411.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQX

10in 2025

2007high 21 (2010) · low 6 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQX

177in 2025

2007high 212 (2022) · low 43 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQX

3in 2024

2007high 49 (2009) · low 0 (2014)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · DQX

2,178in 2025

2007high 2,210 (2024) · low 687 (2009)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 WaveWire/WaveMap Pressure System is intended for use in coronary and peripheral blood vessels to measure blood pressure during diagnostic and/or interventional procedures. The WaveWire may be used to guide the positioning of balloon dilatation catheters, as well as other interventional devices such as atherectomy devices, lasers and stents. Blood pressure measurements are obtained to provide hemodynamic information for the diagnosis and treatment of coronary and/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/K965140 · printed Nov 6, 2026

Cite this page

510(k) Report. “K965140: Cardiometrics Wavewire/Wavemap Pressure System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K965140

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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