510(k) · Cleared
ClearedAudicor Cpam (Cardiopulmonary Ambulatory Monitor)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inovise Medical, Inc. · MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Cleared on Oct 24, 2011 as substantially equivalent to K073545 (Inovise Medical, Inc., 2008) and 1 other predicate after a 238-day review. Its family tree reaches back 6 generations to 1991. 4 later devices descend from it.
- Decided
- Oct 24, 2011
- Review
- 238 days
- Class
- Class II
- Product code
- MLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K910870 (1991). 16 ancestors in all, the oldest K871344 (1987). 4 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK910870 Edentec Model 3711 Digital RecorderEdentec Corp. · 1991
- 5 generations backK963597 Silent Night ILocal Silence, Inc. · 1997
- 4 generations backK981034 Silent Night IISleep Solutions, Inc. · 1998
- 3 generations backK000253 Silent Night VSleep Solutions, Inc. · 2000
- 2 generations backK042745 Lifescreen ApneaDel Mar Reynolds Medical, Inc. · 2005 · Recalled
- 1 generation backK110001 Spacelabs Pathfinder SL Holter AnalyzerSpacelabs Healthcare, Ltd. · 2011 · Recalled
- This deviceK110569 Audicor Cpam (Cardiopulmonary Ambulatory Monitor)Inovise Medical, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK120462 Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep…Inovise Medical, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK131883 Audicor Cpam with SDB (Accelerometer Based)Inovise Medical, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK151433 AUDICOR CA300/CC100 Analyzer with SDBInovise Medical, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK130660 Audicor Cpam with SDB (Single Sensor)Inovise Medical, Inc. · 2013
Most influential descendants
Showing 4 of 4 · See all- K120462Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…Inovise Medical, Inc. · 2012 · cites it directly3descendants
- K131883Audicor Cpam with SDB (Accelerometer Based)Inovise Medical, Inc. · 2014 · 2 generations on1descendant
- K151433AUDICOR CA300/CC100 Analyzer with SDBInovise Medical, Inc. · 2016 · 3 generations on0descendants
- K130660Audicor Cpam with SDB (Single Sensor)Inovise Medical, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K910870 | Edentec Model 3711 Digital Recorder | Edentec Corp. | 1991 | — |
| −5 | K963597 | Silent Night I | Local Silence, Inc. | 1997 | — |
| −4 | K981034 | Silent Night II | Sleep Solutions, Inc. | 1998 | — |
| −3 | K000253 | Silent Night V | Sleep Solutions, Inc. | 2000 | — |
| −2 | K042745 | Lifescreen Apnea | Del Mar Reynolds Medical, Inc. | 2005 | 1 |
| −1 | K110001 | Spacelabs Pathfinder SL Holter Analyzer | Spacelabs Healthcare, Ltd. | 2011 | 1 |
| 0 (this device) | K110569 | Audicor Cpam (Cardiopulmonary Ambulatory Monitor) | Inovise Medical, Inc. | 2011 | — |
| +1 | K120462 | Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep… | Inovise Medical, Inc. | 2012 | — |
| +2 | K131883 | Audicor Cpam with SDB (Accelerometer Based) | Inovise Medical, Inc. | 2014 | — |
| +3 | K151433 | AUDICOR CA300/CC100 Analyzer with SDB | Inovise Medical, Inc. | 2016 | — |
| +2 | K130660 | Audicor Cpam with SDB (Single Sensor) | Inovise Medical, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 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 MLO? 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 MLO device
- #1 K261580 ZBPro Diagnostic (Version 2.0)score 13.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K073545 | Audicor, Hemo Ambulatory MonitorSummary page 2…Predicate ECG and Heart Audicor Hemo Ambulatory Monitor (510O(k) Sound Recording and K073545); Analysis Spacelabs Pathfinder SL (510O(k) K1 10001) Technological The Audi… | 2008 |
| * | K110001 | Spacelabs Pathfinder SL Holter Analyzer Cleared while this submission was under review Summary page 2…r (510O(k) Sound Recording and K073545); Analysis Spacelabs Pathfinder SL (510O(k) K1 10001) Technological The Audicor System and the predicate devices (Spacelabs Pathfinder SL Characteristics and Audicor [Hemo] AM) a… | 2011 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120462 | Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered… | 2012 | 3 |
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 20 years and passes through 6 companies; a new generation was cleared every 4.2 years on median.
- 3 of the 16 ancestors have a recall of any class.
- Of its descendants, K120462 (Inovise Medical, Inc., 2012) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K073545.
How does its category compare?
All MLO devicesMLO Electrocardiograph, Ambulatory, With Analysis Algorithm: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MLO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MLO
238in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MLO
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MLO
4in 2025
MAUDE reports naming product code MLO, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 3 | 238 | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 2 | 2 |
| 2025 | 1 | — | 0 | 4 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Audicor® System, when used with AUDICOR Sensors on the chest wall and properly attached Holter unit, is intended for use on adults 18 years of age and older 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. The Audicor recording may be obtained at any location specified by a physician including home, hospital or clinic. The measurements…
Read the full statement (121 words)
The Audicor® System, when used with AUDICOR Sensors on the chest wall and properly attached Holter unit, is intended for use on adults 18 years of age and older 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. The Audicor recording may be obtained at any location specified by a physician including home, hospital or clinic.
The measurements provided and 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110569 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110569: Audicor Cpam (Cardiopulmonary Ambulatory Monitor).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110569
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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