510(k) · Cleared
ClearedAudicor, Hemo Ambulatory Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inovise Medical, Inc. · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on Sep 9, 2008 as substantially equivalent to K021470 (General Electric Medical Systems Information Techn, 2002) after a 266-day review. Its family tree reaches back 2 generations to 2000. 11 later devices descend from it.
- Decided
- Sep 9, 2008
- Review
- 266 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001317 (2000). 11 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK001317 ARIADel Mar Medical Systems, LLC · 2000
- 1 generation backK021470 Seer Light Compact Digital Holter RecorderGeneral Electric Medical Systems Information Techn · 2002
- This deviceK073545 Audicor, Hemo Ambulatory MonitorInovise Medical, Inc. · 2008
- Descendant · cites it directly · 4 of its ownK192004 Eko Analysis SoftwareEko Devices, Inc. · 2020
- Descendant · cites it directly · 4 of its ownK110569 Audicor Cpam (Cardiopulmonary Ambulatory Monitor)Inovise Medical, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK213794 Eko Murmur Analysis Software (EMAS)Eko Devices, Inc. · 2022
- Descendant · 2 generations on · 3 of its ownK120462 Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep…Inovise Medical, Inc. · 2012
- Descendant · 3 generations on · 1 of its ownK240901 StethophoneSparrow Acoustics, Inc. · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K192004Eko Analysis SoftwareEko Devices, Inc. · 2020 · cites it directly4descendants
- K110569Audicor Cpam (Cardiopulmonary Ambulatory Monitor)Inovise Medical, Inc. · 2011 · cites it directly4descendants
- K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc. · 2022 · 2 generations on3descendants
- K120462Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…Inovise Medical, Inc. · 2012 · 2 generations on3descendants
- K240901StethophoneSparrow Acoustics, Inc. · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001317 | ARIA | Del Mar Medical Systems, LLC | 2000 | — |
| −1 | K021470 | Seer Light Compact Digital Holter Recorder | General Electric Medical Systems Information Techn | 2002 | — |
| 0 (this device) | K073545 | Audicor, Hemo Ambulatory Monitor | Inovise Medical, Inc. | 2008 | — |
| +1 | K192004 | Eko Analysis Software | Eko Devices, Inc. | 2020 | — |
| +1 | K110569 | Audicor Cpam (Cardiopulmonary Ambulatory Monitor) | Inovise Medical, Inc. | 2011 | — |
| +2 | K213794 | Eko Murmur Analysis Software (EMAS) | Eko Devices, Inc. | 2022 | — |
| +2 | K120462 | Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep… | Inovise Medical, Inc. | 2012 | — |
| +3 | K240901 | Stethophone | Sparrow Acoustics, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
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 MWJ? 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 MWJ device
- #1 K254119 Wearable ECG Recorder (YMHeart XY-12)…score 14.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K021470 | Seer Light Compact Digital Holter RecorderSummary page 2…s found to be substantially equivalent to the following cleared devices: * GE Medical Systems SEER Light Holter Recorder (K021470) Technological The Audicor System Hemo wireless ECG/heart sounds data collection harness Characteristics: and th… | 2002 |
What descends from it? (11)
See all 113 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 8 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K192004 (Eko Devices, Inc., 2020) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K021470.
How does its category compare?
All MWJ devicesMWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MWJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MWJ
337in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWJ
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWJ
8in 2025
MAUDE reports naming product code MWJ, 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 | 5 | 142 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 3 | 90 | 0 | 0 |
| 2011 | 3 | 206 | 0 | 0 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 3 | 241 | 0 | 4 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 4 | 337 | 0 | 6 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 2 | — | 2 | 3 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 5 | 270 | 0 | — |
What is it indicated for?
The Audicor® 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 ACG (acoustic cardiograph) report for consideration by physicians. Audicor systems allow detection, reporting and interpretation of standard ECG data as well as advanced parameters such as EMAT, LVST, S3 strength, S4 strength, and SDI. Data may…
Read the full statement (169 words)
The Audicor® 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 ACG (acoustic cardiograph) report for consideration by physicians. Audicor systems allow detection, reporting and interpretation of standard ECG data as well as advanced parameters such as EMAT, LVST, S3 strength, S4 strength, and SDI.
Data may be reported in a single snapshot report and in a trended report format where multiple data points are trended over time. The Audicor system also accepts and analyzes downloads of up to 48 hours of patient data from an optional ambulatory ECG/heart sounds collection device.
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.
https://510kreport.com/device/K073545 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073545: Audicor, Hemo Ambulatory Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073545
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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