510(k) · Cleared
ClearedAurora
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ensodata · MNR Ventilatory Effort Recorder
Cleared on Feb 9, 2024 as substantially equivalent to K182618 (Mycardio, LLC Dba Sleepimage., 2019) after a 275-day review. Its family tree reaches back 9 generations to 1992.
- Decided
- Feb 9, 2024
- Review
- 275 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K913396 (1992). 30 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 5 generations between
- 3 generations backK092003 CPC Sleep Data Recorder, Model M1, and Application SoftwareMyCardio, LLC · 2009
- 2 generations backK163696 SleepImage SystemMycardio, LLC Dba Sleepimage. · 2017
- 1 generation backK182618 SleepImage SystemMycardio, LLC Dba Sleepimage. · 2019
- This deviceK231355 AuroraEnsodata · 2024
Show all 9 generations
- Root · 9 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 8 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- 7 generations backK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- 6 generations backK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- 5 generations backK041904 Compass F10 SystemMedcare Flaga · 2004
- 4 generations backK073682 Embletta GoldEmbla Systems, Inc. · 2008 · Recalled
- 3 generations backK092003 CPC Sleep Data Recorder, Model M1, and Application SoftwareMyCardio, LLC · 2009
- 2 generations backK163696 SleepImage SystemMycardio, LLC Dba Sleepimage. · 2017
- 1 generation backK182618 SleepImage SystemMycardio, LLC Dba Sleepimage. · 2019
- This deviceK231355 AuroraEnsodata · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −8 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| −7 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| −6 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| −5 | K041904 | Compass F10 System | Medcare Flaga | 2004 | — |
| −4 | K073682 | Embletta Gold | Embla Systems, Inc. | 2008 | 1 |
| −3 | K092003 | CPC Sleep Data Recorder, Model M1, and Application Software | MyCardio, LLC | 2009 | — |
| −2 | K163696 | SleepImage System | Mycardio, LLC Dba Sleepimage. | 2017 | — |
| −1 | K182618 | SleepImage System | Mycardio, LLC Dba Sleepimage. | 2019 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K182618 | SleepImage SystemSummary page 6…510k: K231355 Aurora 510(k): K182618 IV. SUBJECT DEVICE DESCRIPTION Aurora is a Class II Software as a Medical Device (SaMD), intended to aid in the evaluatio… | 2019 |
| † | K202142 | Sleepware G3 | 2020 |
| † | K153353 | Sandman Elite | 2016 |
| † | K161650 | Polysmith Sleep System, Model NTI7593 | 2017 |
| † | K191088 | Checkme O2 Pulse Oximeter | 2019 |
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 32 years and passes through 9 companies; a new generation was cleared every 3.9 years on median.
- 2 of the 30 ancestors have a recall of any class.
- 1 other device also cites its predicate K182618.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Aurora is a Software as a Medical Device (SaMD) that establishes sleep quality. Aurora automatically analyzes, displays, and summarizes Photoplethysmogram (PPG) data collected during sleep using compatible devices. Aurora is intended for use by and by order of a healthcare professional to aid in the diagnosis of sleep disorders including sleep apnea in adults The Aurora output, including automatically detected respiratory events and parameters, may be…
Read the full statement (103 words)
Aurora is a Software as a Medical Device (SaMD) that establishes sleep quality. Aurora automatically analyzes, displays, and summarizes Photoplethysmogram (PPG) data collected during sleep using compatible devices. Aurora is intended for use by and by order of a healthcare professional to aid in the diagnosis of sleep disorders including sleep apnea in adults
The Aurora output, including automatically detected respiratory events and parameters, may be displayed and edited by a qualified healthcare professional. The Aurora output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional.
Aurora is not intended for use with polysomnography devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231355 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231355: Aurora.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231355
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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