510(k) Report

FDA applicant

Cardio Metrics, Inc.

Mountain View, CA23 decisions1986–19971 recall

FDA records 23 decisions for Cardio Metrics, Inc. (Mountain View, CA) from 1986 to 1997: 23 510(k) clearances. Most are in product codes DQX (Wire, Guide, Catheter) and ITX (Transducer, Ultrasonic, Diagnostic). Its devices cite 11 predicates, 9 of them its own earlier devices. 1 recall is linked to its devices.

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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Cardio Metrics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardio Metrics, Inc. since 2007.

Recalls per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Cardio Metrics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cardio Metrics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DQXWire, Guide, Catheter9decisions
  • ITXTransducer, Ultrasonic, Diagnostic4decisions
  • DPWFlowmeter, Blood, Cardiovascular4decisions
  • GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered1decision
  • JOPTransducer, Ultrasonic1decision
  • KRIAccessory Equipment, Cardiopulmonary Bypass1decision

Also: DTP (1), DTY (1), IYO (1).

Whose devices does it build on?

Its devices cite 11 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 9 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K965140Cardiometrics Wavewire/Wavemap Pressure SystemCardio Metrics, Inc. · 19975cite it
  • K921563Cardiometrics Flowire/Flomap SystemCardio Metrics, Inc. · 19923cite it
  • K912776Cardiometrics Flowire/Flomap Doppler UltrasoundCardio Metrics, Inc. · 19922cite it
  • K905411Flowire and FlomapCardio Metrics, Inc. · 19912cite it
  • K972762Cardiometrics Flowire 300 and XT 300 Doppler Guide WiresCardio Metrics, Inc. · 19972cite it
  • K932536Cardiometrics Flowire & FlomapCardio Metrics, Inc. · 19931cites it

What has FDA decided for it lately?

  • K972762Cardiometrics Flowire 300 and XT 300 Doppler Guide WiresCardio Metrics, Inc. · 19971 recall
  • K965140Cardiometrics Wavewire/Wavemap Pressure SystemCardio Metrics, Inc. · 1997
  • K951567Cardiometics Flowire, Smartwire Doppler Guide WireCardio Metrics, Inc. · 1996
  • K961777Accutrac XT Intravascular Guide Wire (Floppy) Model 2403/(Flex) Model 2404Cardio Metrics, Inc. · 1996
  • K955551CARDI0METRICS Flow Wire XT Doppler Guide Model 1403, 1404Cardio Metrics, Inc. · 1996
  • K954913Cardiometrics Accutrac Intravascular Guide Wire (Modification)Cardio Metrics, Inc. · 1995
  • K952562Cardiometrics Accutrac Intravascular Guide WireCardio Metrics, Inc. · 1995
  • K943022Cardiometrics Flowire Doppler Guide WireCardio Metrics, Inc. · 1994

All 23 as Cardio Metrics, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K972762FloWire Doppler Guide wires. Volcano Corporation, Rancho Cardova, Ca. The Volcano…Oct 6, 2009