510(k) Report

510(k) · Cleared

Cleared

Audicor 200 System, Models 200D and 200S

K070136510(k) TraditionalCleared Apr 13, 200787-day reviewClass II21 CFR 870.2340

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

Inovise Medical, Inc. · DPS Electrocardiograph

Cleared on Apr 13, 2007 as substantially equivalent to K043074 (Inovise Medical, Inc., 2005) and 1 other predicate after an 87-day review. Its family tree reaches back 5 generations to 1992.

Decided
Apr 13, 2007
Review
87 days
Class
Class II
Product code
DPS
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K920626 (1992). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestorK920626 · Model Eli 200 Electrocardiograph · Mortara Instrument, Inc. · 1992K031182 · Eli 200+ Audicor · Mortara Instrument, Inc. · 2003K032145 · Audicor Upgrade System · Inovise Medical, Inc. · 2003K043074 · Liberty System · Inovise Medical, Inc. · 2005 · recalledK051450 · Extended Measurements System · Inovise Medical, Inc. · 20051990199520002005
Other ancestors, by generation 3 generations back: 1 other ancestor K051450 · Extended Measurements System · Inovise Medical, Inc. · 2005K043074 · Liberty System · Inovise Medical, Inc. · 2005 · recalledK032145 · Audicor Upgrade System · Inovise Medical, Inc. · 2003K031182 · Eli 200+ Audicor · Mortara Instrument, Inc. · 2003K920626 · Model Eli 200 Electrocardiograph · Mortara Instrument, Inc. · 1992−50
  1. Root · 5 generations backK920626 Model Eli 200 ElectrocardiographMortara Instrument, Inc. · 1992
  2. 4 generations backK031182 Eli 200+ AudicorMortara Instrument, Inc. · 2003
  3. 3 generations backK032145 Audicor Upgrade SystemInovise Medical, Inc. · 2003
  4. 2 generations backK043074 Liberty SystemInovise Medical, Inc. · 2005 · Recalled
  5. 1 generation backK051450 Extended Measurements SystemInovise Medical, Inc. · 2005
  6. This deviceK070136 Audicor 200 System, Models 200D and 200SInovise Medical, Inc. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K920626Model Eli 200 ElectrocardiographMortara Instrument, Inc.1992—
−4K031182Eli 200+ AudicorMortara Instrument, Inc.2003—
−3K032145Audicor Upgrade SystemInovise Medical, Inc.2003—
−2K043074Liberty SystemInovise Medical, Inc.20051
−1K051450Extended Measurements SystemInovise Medical, Inc.2005—
0 (this device)K070136Audicor 200 System, Models 200D and 200SInovise Medical, Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
FIG. 1 — Lineage of K070136, 1992–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

Planning a device in DPS? 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 DPS device

  1. #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K043074Liberty System
Summary page 2
…c Devices Substantial The Inovise Audicor 200 System with added interpretive statements is substantially Equivalence: equivalent to the AUDICOR® 200 system (K043074, cleared as Liberty) with the incorporation of Audicor Advanced Parameters (K051450, cleared as Extended…
Inovise Medical, Inc.20051
*K051450Extended Measurements System
Summary page 2
…antially Equivalence: equivalent to the AUDICOR® 200 system (K043074, cleared as Liberty) with the incorporation of Audicor Advanced Parameters (K051450, cleared as Extended Measurements) Technological The SDI modification to the Audicor 200 System and the A…
Inovise Medical, Inc.2005—

Also cleared against K043074: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • 1 other device also cites its predicate K043074.

How does its category compare?

All DPS devices

DPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · DPS

6in 2025

2007: 112008: 132009: 142010: 112011: 222012: 122013: 102014: 112015: 82016: 112017: 92018: 142019: 32020: 62021: 52022: 62023: 102024: 82025: 62026 (partial year): 6
2007high 22 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DPS

163in 2025

2007: 87 days median2008: 31 days median2009: 84 days median2010: 104 days median2011: 154 days median2012: 117 days median2013: 134 days median2014: 253 days median2015: 178 days median2016: 229 days median2017: 177 days median2018: 221 days median2019: 178 days median2020: 224 days median2021: 135 days median2022: 244 days median2023: 236 days median2024: 260 days median2025: 163 days median2026 (partial year): 258 days median
2007high 260 (2024) · low 31 (2008)2026

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

Recalls per year · DPS

3in 2025

2007: 22009: 12010: 22011: 12019: 92020: 22021: 12022: 12023: 32024: 4, 1 Class I2025: 32026 (partial year): 4
2007high 9 (2019) · low 0 (2008)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · DPS

55in 2025

2007: 92008: 172009: 142010: 212011: 1212012: 562013: 152014: 152015: 302016: 122017: 152018: 192019: 272020: 592021: 242022: 592023: 542024: 642025: 55
2007high 121 (2011) · low 9 (2007)2025

MAUDE reports naming product code DPS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007118729
20081331017
20091484114
201011104221
2011221541121
201212117056
201310134015
201411253015
20158178030
201611229012
20179177015
201814221019
20193178927
20206224259
20215135124
20226244159
202310236354
202482604 (1)64
20256163355
202662584—

What is it indicated for?

The Audicor 200 System, when used with AUDICOR Sensors on the chest wall, is intended for use in acquiring, analyzing and reporting ECG and heart sound data and to provide interpretation of the data in an integrated report for consideration by physicians. In addition, the Audicor 200 System can be used with an add-on laptop computer that allows data to be presented in the format of real-time and trended display of advanced parameters derived from…

Read the full statement (137 words)

The Audicor 200 System, when used with AUDICOR Sensors on the chest wall, is intended for use in acquiring, analyzing and reporting ECG and heart sound data and to provide interpretation of the data in an integrated report for consideration by physicians. In addition, the Audicor 200 System can be used with an add-on laptop computer that allows data to be presented in the format of real-time and trended display of advanced parameters derived from simultaneous ECG data and heart sounds data.

The interpretations of ECG and heart sound data offered by the device are only significant when used in conjunction with physician over read as well as consideration of other relevant patient data.

The device is intended for use only under the direct supervision of a physician, and is for use on adults (> 18 years).

Indications for use as stated in the FDA summary.

Also cleared against K043074

1 other device cites the same predicate.

  • K051450Extended Measurements SystemInovise Medical, Inc. · 2005

More from Inovise Medical, Inc.

14 FDA decisions under this applicant name. See the company

  • 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

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https://510kreport.com/device/K070136 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070136: Audicor 200 System, Models 200D and 200S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070136

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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