510(k) Report

FDA applicant

Inovise Medical, Inc.

Beaverton, OR14 decisions2000–20161 recall

FDA records 14 decisions for Inovise Medical, Inc. (Beaverton, OR) from 2000 to 2016: 14 510(k) clearances. Most are in product codes DPS (Electrocardiograph) and MLO (Electrocardiograph, Ambulatory, With Analysis…). Its devices cite 20 predicates, 11 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 Inovise Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2007: 12008: 22011: 22012: 12013: 12014: 12016: 1
2007high 2 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Inovise Medical, 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?

  • DPSElectrocardiograph3decisions
  • MLOElectrocardiograph, Ambulatory, With Analysis Algorithm3decisions
  • DQDStethoscope, Electronic2decisions
  • DRXElectrode, Electrocardiograph2decisions
  • MNRVentilatory Effort Recorder2decisions
  • MWJElectrocardiograph, Ambulatory (Without Analysis)2decisions

Whose devices does it build on?

Its devices cite 20 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 16 times; 11 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.

  • K032145Audicor Upgrade SystemInovise Medical, Inc. · 20033cite it
  • K073545Audicor, Hemo Ambulatory MonitorInovise Medical, Inc. · 20083cite it
  • K043074Liberty SystemInovise Medical, Inc. · 20052cite it
  • K120462Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered Breathing Detection)Inovise Medical, Inc. · 20122cite it
  • K080602Audicor Sensor, Models: 2.0, 3.0Inovise Medical, Inc. · 20081cites it
  • K051450Extended Measurements SystemInovise Medical, Inc. · 20051cites it

What has FDA decided for it lately?

  • K151433AUDICOR CA300/CC100 Analyzer with SDBInovise Medical, Inc. · 2016
  • K131883Audicor Cpam with SDB (Accelerometer Based)Inovise Medical, Inc. · 2014
  • K130660Audicor Cpam with SDB (Single Sensor)Inovise Medical, Inc. · 2013
  • K120462Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered Breathing Detection)Inovise Medical, Inc. · 2012
  • K110569Audicor Cpam (Cardiopulmonary Ambulatory Monitor)Inovise Medical, Inc. · 2011
  • K103516Audicor Sensor-Adapter Model Audicor Sensor-Adapter 4.0Inovise Medical, Inc. · 2011
  • K080602Audicor Sensor, Models: 2.0, 3.0Inovise Medical, Inc. · 2008
  • K073545Audicor, Hemo Ambulatory MonitorInovise Medical, Inc. · 2008

All 14 as Inovise Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K043074AUDICOR 200 D Inovise Part Number 30047 (console part number 20158).Jan 12, 2003