510(k) · Cleared
ClearedProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prosomnus Sleep Technologies, Inc. · LRK Device, Anti-Snoring
Cleared on Nov 20, 2020 as substantially equivalent to K133683 (Microdental, Inc., 2014) and 1 other predicate after an 80-day review. Its family tree reaches back 10 generations to 1989. 2 later devices descend from it.
- Decided
- Nov 20, 2020
- Review
- 80 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K882303 (1989). 12 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 6 generations between
- 3 generations backK140278 Somnodent Fusion, Classic; Somnodent Fusion, FlexSomnomed, Inc. · 2014
- 2 generations backK150369 SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with…Somnomed, Inc. · 2015
- 1 generation backK161624 MicrO2 OSA Device with Micro-RecorderMicrodental, Inc. · 2016
- This deviceK202529 ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore…Prosomnus Sleep Technologies, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK252765 ProSomnus RPMO2 OSA Device (RPMO2 OSA)Prosomnus Sleep Technologies · 2026
- Descendant · 2 generations on · 0 of its ownK254304 iNOS intraoral biosensorAchaemenid, LLC · 2026
Show all 10 generations
- Root · 10 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 9 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 8 generations backK042161 Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd. · 2004
- 7 generations backK050592 Somnomed Mas RxaSomnomed, Ltd. · 2005
- 6 generations backK073004 Somnomed BflexSomnomed, Inc. · 2008
- 5 generations backK121340 Somnodent G2Somnomed, Inc. · 2012
- 4 generations backK130558 Somnodent Herbst; Classic, FlexSomnomed, Inc. · 2013
- 3 generations backK140278 Somnodent Fusion, Classic; Somnodent Fusion, FlexSomnomed, Inc. · 2014
- 2 generations backK150369 SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with…Somnomed, Inc. · 2015
- 1 generation backK161624 MicrO2 OSA Device with Micro-RecorderMicrodental, Inc. · 2016
- This deviceK202529 ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore…Prosomnus Sleep Technologies, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −9 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −8 | K042161 | Anti-Snoring/Sleep Apnea Device | Rj & VK Bird Pty, Ltd. | 2004 | — |
| −7 | K050592 | Somnomed Mas Rxa | Somnomed, Ltd. | 2005 | — |
| −6 | K073004 | Somnomed Bflex | Somnomed, Inc. | 2008 | — |
| −5 | K121340 | Somnodent G2 | Somnomed, Inc. | 2012 | — |
| −4 | K130558 | Somnodent Herbst; Classic, Flex | Somnomed, Inc. | 2013 | — |
| −3 | K140278 | Somnodent Fusion, Classic; Somnodent Fusion, Flex | Somnomed, Inc. | 2014 | — |
| −2 | K150369 | SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac… | Somnomed, Inc. | 2015 | — |
| −1 | K161624 | MicrO2 OSA Device with Micro-Recorder | Microdental, Inc. | 2016 | — |
| 0 (this device) | K202529 | ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device… | Prosomnus Sleep Technologies, Inc. | 2020 | — |
| +1 | K252765 | ProSomnus RPMO2 OSA Device (RPMO2 OSA) | Prosomnus Sleep Technologies | 2026 | — |
| +2 | K254304 | iNOS intraoral biosensor | Achaemenid, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 LRK? 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 LRK device
- #1 K252531 Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for…score 16.3 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K133683 | MICR02 Osa DeviceSummary page 4…oring) Panel: Dental 3. Predicate Device Device Name: ProSomnus® MicrO2 Obstructive Sleep Apnea Device 510(k) Number: K133683 Reference Device Device Name: ProSomnus® MicrO2 Obstructive Sleep Apnea Device with… | 2014 |
| * | K161624 | MicrO2 OSA Device with Micro-RecorderSummary page 5…Device Name: ProSomnus® MicrO2 Obstructive Sleep Apnea Device with Micro-Recorder 510(k) Number: K161624 4. Device Description The ProSomnus® EVO Sleep and Snore Device is an oral device, which improves the flow of air through t… | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252765 | ProSomnus RPMO2 OSA Device (RPMO2 OSA) | 2026 | 1 |
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 31 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K252765 (Prosomnus Sleep Technologies, 2026) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K133683.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · LRK
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LRK
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LRK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LRK
653in 2025
MAUDE reports naming product code LRK, 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 | 3 | 109 | 0 | 1 |
| 2009 | 3 | 88 | 2 | 11 |
| 2010 | 8 | 195 | 0 | 7 |
| 2011 | 10 | 134 | 0 | 69 |
| 2012 | 10 | 142 | 0 | 445 |
| 2013 | 9 | 233 | 0 | 72 |
| 2014 | 11 | 219 | 0 | 49 |
| 2015 | 6 | 117 | 0 | 28 |
| 2016 | 10 | 157 | 0 | 18 |
| 2017 | 7 | 170 | 0 | 32 |
| 2018 | 10 | 200 | 0 | 61 |
| 2019 | 13 | 150 | 0 | 56 |
| 2020 | 5 | 80 | 0 | 24 |
| 2021 | 10 | 126 | 0 | 49 |
| 2022 | 11 | 154 | 0 | 40 |
| 2023 | 5 | 156 | 0 | 50 |
| 2024 | 6 | 254 | 0 | 185 |
| 2025 | 14 | 107 | 1 | 653 |
| 2026 | 10 | 63 | 1 | — |
What is it indicated for?
The ProSomnus® EVO Sleep and Snore Device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Optionally, if the DentiTrac micro-recorder is completely embedded in the ProSomnus9 EVO Sleep and Snore Device, the micro-recorder is intended to measure patient compliance to oral device/appliance therapy in combination with the DentiTrac System.
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/K202529 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202529: ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202529
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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