510(k) · Cleared
ClearedCPC Sleep Data Recorder, Model M1, and Application Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MyCardio, LLC · MNR Ventilatory Effort Recorder
Cleared on Sep 30, 2009 as substantially equivalent to K073682 (Embla Systems, Inc., 2008) after a 90-day review. Its family tree reaches back 6 generations to 1992. 4 later devices descend from it.
- Decided
- Sep 30, 2009
- Review
- 90 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K913396 (1992). 27 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 5 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- 4 generations backK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- 3 generations backK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- 2 generations backK041904 Compass F10 SystemMedcare Flaga · 2004
- 1 generation backK073682 Embletta GoldEmbla Systems, Inc. · 2008 · Recalled
- This deviceK092003 CPC Sleep Data Recorder, Model M1, and Application SoftwareMyCardio, LLC · 2009
- Descendant · cites it directly · 3 of its ownK163696 SleepImage SystemMycardio, LLC Dba Sleepimage. · 2017
- Descendant · 2 generations on · 2 of its ownK182618 SleepImage SystemMycardio, LLC Dba Sleepimage. · 2019
- Descendant · 3 generations on · 0 of its ownK252628 CassieWesper, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK231355 AuroraEnsodata · 2024
Most influential descendants
Showing 4 of 4 · See all- K163696SleepImage SystemMycardio, LLC Dba Sleepimage. · 2017 · cites it directly3descendants
- K182618SleepImage SystemMycardio, LLC Dba Sleepimage. · 2019 · 2 generations on2descendants
- K252628CassieWesper, Inc. · 2026 · 3 generations on0descendants
- K231355AuroraEnsodata · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −5 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| −4 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| −3 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| −2 | K041904 | Compass F10 System | Medcare Flaga | 2004 | — |
| −1 | K073682 | Embletta Gold | Embla Systems, Inc. | 2008 | 1 |
| 0 (this device) | K092003 | CPC Sleep Data Recorder, Model M1, and Application Software | MyCardio, LLC | 2009 | — |
| +1 | K163696 | SleepImage System | Mycardio, LLC Dba Sleepimage. | 2017 | — |
| +2 | K182618 | SleepImage System | Mycardio, LLC Dba Sleepimage. | 2019 | — |
| +3 | K252628 | Cassie | Wesper, Inc. | 2026 | — |
| +3 | K231355 | Aurora | Ensodata | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 6 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K073682 | Embletta GoldSummary page 1…TBD F. Device Class: Class II G. Classification Panel: TBD PREDICATE DEVICE Trade Name: Embletta Gold, 510(k) Number: K073682 Page 1 of 5 Traditional 510(k) Notification for th… | 2008 |
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 |
|---|---|---|---|
| K163696 | SleepImage System | 2017 | 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 17 years and passes through 7 companies; a new generation was cleared every 3.9 years on median.
- 2 of the 27 ancestors have a recall of any class.
- Of its descendants, K163696 (Mycardio, LLC Dba Sleepimage., 2017) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K073682.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
The M1 sleep data recording device is intended for use by a physician or a trained technician for the collection of physiological (Actigraphy) and Electrocardiogram (ECG) recordings during sleep that will be used for screening different sleep associated disorders. The intended environment is any dry space used for sleeping. The CPC application software (and associated modules) is intended for use by a physician or a trained technician for the analysis…
Read the full statement (115 words)
The M1 sleep data recording device is intended for use by a physician or a trained
technician for the collection of physiological (Actigraphy) and Electrocardiogram
(ECG) recordings during sleep that will be used for screening different sleep
associated disorders.
The intended environment is any dry space used for sleeping.
The CPC application software (and associated modules) is intended for use by a
physician or a trained technician for the analysis, manipulation and final presentation
of physiological (Actigraphy) and Electrocardiogram (ECG) recordings during sleep.
The intended environment is any dry space suitable for the operation of a
conventional computer.
The device and software do not monitor or diagnose the patient and do not issue any
alarms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092003 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092003: CPC Sleep Data Recorder, Model M1, and Application Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092003
Report an extraction error
Are you the manufacturer?
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