510(k) · Cleared
ClearedAudicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered Breathing Detection)
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 Sep 20, 2012 as substantially equivalent to K110569 (Inovise Medical, Inc., 2011) and 2 other predicates after a 218-day review. Its family tree reaches back 8 generations to 1991. 3 later devices descend from it.
- Decided
- Sep 20, 2012
- Review
- 218 days
- Class
- Class II
- Product code
- MLO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K910772 (1991). 43 ancestors in all, the oldest K871344 (1987). 3 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 7 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 6 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 5 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 4 generations backK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
- 3 generations backK041156 Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc. · 2004 · Recalled
- 2 generations backK043359 4100 Patient Oximeter ModuleNonin Medical, Inc. · 2005
- 1 generation backK082113 Nox T3, Noxturnal (PC Application)Nox Medical · 2008 · Recalled
- This deviceK120462 Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep…Inovise Medical, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK131883 Audicor Cpam with SDB (Accelerometer Based)Inovise Medical, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK151433 AUDICOR CA300/CC100 Analyzer with SDBInovise Medical, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK130660 Audicor Cpam with SDB (Single Sensor)Inovise Medical, Inc. · 2013
Most influential descendants
Showing 3 of 3 · See all- K131883Audicor Cpam with SDB (Accelerometer Based)Inovise Medical, Inc. · 2014 · cites it directly1descendant
- K151433AUDICOR CA300/CC100 Analyzer with SDBInovise Medical, Inc. · 2016 · 2 generations on0descendants
- K130660Audicor Cpam with SDB (Single Sensor)Inovise Medical, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −7 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −6 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −5 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −4 | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor | Nonin Medical, Inc. | 2002 | — |
| −3 | K041156 | Avant Digital Pulse Oximetry System, Models 4000, 4001 | Nonin Medical, Inc. | 2004 | 1 |
| −2 | K043359 | 4100 Patient Oximeter Module | Nonin Medical, Inc. | 2005 | — |
| −1 | K082113 | Nox T3, Noxturnal (PC Application) | Nox Medical | 2008 | 1 |
| 0 (this device) | K120462 | Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep… | Inovise Medical, Inc. | 2012 | — |
| +1 | K131883 | Audicor Cpam with SDB (Accelerometer Based) | Inovise Medical, Inc. | 2014 | — |
| +2 | K151433 | AUDICOR CA300/CC100 Analyzer with SDB | Inovise Medical, Inc. | 2016 | — |
| +1 | 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 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K110569 | Audicor Cpam (Cardiopulmonary Ambulatory Monitor)Summary page 2…for reporting of sleep disordered breathing, snoring and Equivalence: activity are substantially equivalent to: 1. AudicorCPAM (510(k) K110569), and 2. Spacelabs Healthcare Pathfinder SL Holter Analyzer (510(k) K1i10001) 3.… | 2011 |
| * | K110001 | Spacelabs Pathfinder SL Holter Analyzer | 2011 |
| * | K082113 | Nox T3, Noxturnal (PC Application)Summary page 2…and 2. Spacelabs Healthcare Pathfinder SL Holter Analyzer (510(k) K1i10001) 3. Nox Medical Nox T3 Sleep Recorder (510(k) K0821 13) Technological The Audicor System and the predicate devices are technologically equivalent in Characteristics:… | 2008 |
What descends from it? (3)
2 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 21 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 6 of the 43 ancestors have a recall of any class.
- Of its descendants, K131883 (Inovise Medical, Inc., 2014) has gone furthest, with 1 descendant of its own.
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. 2012, 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 Hoiter unit, is intended for use on adults 18 years of age and older in acquiring, analyzing and reporting EGG, heart sound, sleep disordered breathing and snoring detection and to provide interpretation of the data in an integrated report for consideration by physicians. The sleep disordered breathing analysis and reporting is intended for use on adult patients…
Read the full statement (154 words)
The AUDICOR System when used with AUDICOR Sensors on the chest wall and properly attached Hoiter unit, is intended for use on adults 18 years of age and older in acquiring, analyzing and reporting EGG, heart sound, sleep disordered breathing and snoring detection and to provide interpretation of the data in an integrated report for consideration by physicians. The sleep disordered breathing analysis and reporting is intended for use on adult patients only as a screening device for obstructive or mixed apnea to determine the need for evaluation by polysomnography based on the patient's score.
Subjects screened for sleep disordered breathing should have periods of sleep of at least 4 hours duration during which the EGG is predominantly sinus rhythm in nature. The AUDICOR recording may be obtained at any location specified by a physician including home, hospital or clinic.
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/K120462 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120462: Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered Breathing Detection).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120462
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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