510(k) · Cleared
ClearedCassie
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wesper, Inc. · MNR Ventilatory Effort Recorder
Cleared on Apr 27, 2026 as substantially equivalent to K182618 (Mycardio, LLC Dba Sleepimage., 2019) after a 250-day review. Its family tree reaches back 9 generations to 1992.
- Decided
- Apr 27, 2026
- Review
- 250 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 deviceK252628 CassieWesper, Inc. · 2026
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 deviceK252628 CassieWesper, Inc. · 2026
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) | K252628 | Cassie | Wesper, Inc. | 2026 | — |
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 5…Number: 21 CFR 868.2375 Product Code: MNR Device Classification: Class II Classification Panel: Anesthesiology Predicate Device Device Trade Name: SleepImage System – K182618 Device Manufacturer: SleepImage Regulation Number: 21 CFR 868.2375 Product Code: MNR Device Classification: Class II Reference… | 2019 |
| † | K231355 | Aurora | 2024 |
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 34 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. 2026, 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?
Cassie is a Software as a Medical Device (SaMD) that automatically analyzes, displays, and summarizes Photoplethysmogram (PPG) data, typically collected during sleep using compatible devices. Cassie is intended for use by and by order of a healthcare professional to aid in the evaluation of sleep disorders, where it may inform or drive clinical management for adults. The Wesper Apnea Hypopnea Index (wAHI) and other outputs presented when oximeter data is…
Read the full statement (105 words)
Cassie is a Software as a Medical Device (SaMD) that automatically analyzes, displays, and summarizes Photoplethysmogram (PPG) data, typically collected during sleep using compatible devices. Cassie is intended for use by and by order of a healthcare professional to aid in the evaluation of sleep disorders, where it may inform or drive clinical management for adults. The Wesper Apnea Hypopnea Index (wAHI) and other outputs presented when oximeter data is available are intended to aid healthcare professionals in diagnosis and management of sleep disordered breathing.
The Cassie output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252628 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252628: Cassie.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252628
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026