510(k) · Cleared
ClearedAUDICOR CA300/CC100 Analyzer with SDB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inovise Medical, Inc. · MNR Ventilatory Effort Recorder
Cleared on Mar 18, 2016 as substantially equivalent to K131883 (Inovise Medical, Inc., 2014) after a 295-day review. Its family tree reaches back 10 generations to 1991.
- Decided
- Mar 18, 2016
- Review
- 295 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K910772 (1991). 45 ancestors in all, the oldest K871344 (1987). No later device cites it as a predicate yet.
- Root · 10 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 6 generations between
- 3 generations backK082113 Nox T3, Noxturnal (PC Application)Nox Medical · 2008 · Recalled
- 2 generations backK120462 Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep…Inovise Medical, Inc. · 2012
- 1 generation backK131883 Audicor Cpam with SDB (Accelerometer Based)Inovise Medical, Inc. · 2014
- This deviceK151433 AUDICOR CA300/CC100 Analyzer with SDBInovise Medical, Inc. · 2016
Show all 10 generations
- Root · 10 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 9 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 8 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 7 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 6 generations backK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
- 5 generations backK041156 Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc. · 2004 · Recalled
- 4 generations backK043359 4100 Patient Oximeter ModuleNonin Medical, Inc. · 2005
- 3 generations backK082113 Nox T3, Noxturnal (PC Application)Nox Medical · 2008 · Recalled
- 2 generations backK120462 Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep…Inovise Medical, Inc. · 2012
- 1 generation backK131883 Audicor Cpam with SDB (Accelerometer Based)Inovise Medical, Inc. · 2014
- This deviceK151433 AUDICOR CA300/CC100 Analyzer with SDBInovise Medical, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −9 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −8 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −7 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −6 | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor | Nonin Medical, Inc. | 2002 | — |
| −5 | K041156 | Avant Digital Pulse Oximetry System, Models 4000, 4001 | Nonin Medical, Inc. | 2004 | 1 |
| −4 | K043359 | 4100 Patient Oximeter Module | Nonin Medical, Inc. | 2005 | — |
| −3 | K082113 | Nox T3, Noxturnal (PC Application) | Nox Medical | 2008 | 1 |
| −2 | 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 | — |
| 0 (this device) | K151433 | AUDICOR CA300/CC100 Analyzer with SDB | Inovise Medical, Inc. | 2016 | — |
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 |
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 MNR? 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 MNR device
- #1 K244027 Sansa Hsatscore 18.1 · 12 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 |
|---|---|---|---|
| * | K131883 | Audicor Cpam with SDB (Accelerometer Based)Summary page 5…on of a physician in a hospital or clinic environment. Technological Characteristics: Characteristic Subject Device Predicate (K131883) Intended Use AUDICOR CA300/CC100 The AUDICOR System when… | 2014 |
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 25 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 6 of the 45 ancestors have a recall of any class.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MNR
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MNR
165in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNR
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNR
43in 2025
MAUDE reports naming product code MNR, 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 | 6 | 124 | 2 | 1 |
| 2008 | 14 | 118 | 0 | 0 |
| 2009 | 8 | 89 | 1 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 9 | 90 | 1 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 4 | 161 | 0 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 4 | 229 | 0 | 4 |
| 2016 | 3 | 281 | 0 | 10 |
| 2017 | 4 | 275 | 0 | 4 |
| 2018 | 3 | 147 | 0 | 2 |
| 2019 | 8 | 383 | 0 | 3 |
| 2020 | 5 | 192 | 0 | 5 |
| 2021 | 3 | 137 | 1 | 5 |
| 2022 | 7 | 266 | 0 | 4 |
| 2023 | 6 | 183 | 0 | 13 |
| 2024 | 6 | 217 | 0 | 11 |
| 2025 | 10 | 165 | 0 | 43 |
| 2026 | 5 | 227 | 1 | — |
What is it indicated for?
AUDICOR CA300/CC100 Analyzer with SDB is a software-only system intended to be used to analyze recordings from AUDICOR-compatible recording devices. AUDICOR CA300/CC100 Analyzer with SDB is capable of analyzing, editing, storing and reporting ECG, heart sound, sleep-disordered breathing (SDB), snoring detection, body position and activity level. An interpretation of the analysis results is produced in an integrated report for consideration by physicians.…
Read the full statement (156 words)
AUDICOR CA300/CC100 Analyzer with SDB is a software-only system intended to be used to analyze recordings from AUDICOR-compatible recording devices.
AUDICOR CA300/CC100 Analyzer with SDB is capable of analyzing, editing, storing and reporting ECG, heart sound, sleep-disordered breathing (SDB), snoring detection, body position and activity level. An interpretation of the analysis results is produced in an integrated report for consideration by physicians.
The AUDICOR CA300/CC100 Analyzer with SDB software is intended for use on adults 18 years of age and older.
The SDB analysis and reporting is intended for use on adult patients as a screening device for obstructive or mixed apnea to determine the need for evaluation by polysomnography based on the patient’s score. Patients screened for SDB should have periods of sleep of at least 4 hours duration.
AUDICOR CA300/CC100 Analyzer with SDB is intended to be used by trained operators under the direct supervision of a physician in a hospital or clinic environment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151433 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151433: AUDICOR CA300/CC100 Analyzer with SDB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151433
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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