510(k) · Cleared
ClearedProSomnus RPMO2 OSA Device (RPMO2 OSA)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prosomnus Sleep Technologies · PLC Sleep Appliances With Patient Monitoring
Cleared on Apr 6, 2026 as substantially equivalent to K202529 (Prosomnus Sleep Technologies, Inc., 2020) after a 220-day review. Its family tree reaches back 11 generations to 1989. 1 later device descends from it.
- Decided
- Apr 6, 2026
- Review
- 220 days
- Class
- Class II
- Product code
- PLC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K882303 (1989). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 7 generations between
- 3 generations backK150369 SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with…Somnomed, Inc. · 2015
- 2 generations backK161624 MicrO2 OSA Device with Micro-RecorderMicrodental, Inc. · 2016
- 1 generation backK202529 ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore…Prosomnus Sleep Technologies, Inc. · 2020
- This deviceK252765 ProSomnus RPMO2 OSA Device (RPMO2 OSA)Prosomnus Sleep Technologies · 2026
- Descendant · cites it directly · 0 of its ownK254304 iNOS intraoral biosensorAchaemenid, LLC · 2026
Show all 11 generations
- Root · 11 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 10 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 9 generations backK042161 Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd. · 2004
- 8 generations backK050592 Somnomed Mas RxaSomnomed, Ltd. · 2005
- 7 generations backK073004 Somnomed BflexSomnomed, Inc. · 2008
- 6 generations backK121340 Somnodent G2Somnomed, Inc. · 2012
- 5 generations backK130558 Somnodent Herbst; Classic, FlexSomnomed, Inc. · 2013
- 4 generations backK140278 Somnodent Fusion, Classic; Somnodent Fusion, FlexSomnomed, Inc. · 2014
- 3 generations backK150369 SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with…Somnomed, Inc. · 2015
- 2 generations backK161624 MicrO2 OSA Device with Micro-RecorderMicrodental, Inc. · 2016
- 1 generation backK202529 ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore…Prosomnus Sleep Technologies, Inc. · 2020
- This deviceK252765 ProSomnus RPMO2 OSA Device (RPMO2 OSA)Prosomnus Sleep Technologies · 2026
Most influential descendants
Showing 1 of 1 · See all- K254304iNOS intraoral biosensorAchaemenid, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −10 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −9 | K042161 | Anti-Snoring/Sleep Apnea Device | Rj & VK Bird Pty, Ltd. | 2004 | — |
| −8 | K050592 | Somnomed Mas Rxa | Somnomed, Ltd. | 2005 | — |
| −7 | K073004 | Somnomed Bflex | Somnomed, Inc. | 2008 | — |
| −6 | K121340 | Somnodent G2 | Somnomed, Inc. | 2012 | — |
| −5 | K130558 | Somnodent Herbst; Classic, Flex | Somnomed, Inc. | 2013 | — |
| −4 | K140278 | Somnodent Fusion, Classic; Somnodent Fusion, Flex | Somnomed, Inc. | 2014 | — |
| −3 | K150369 | SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac… | Somnomed, Inc. | 2015 | — |
| −2 | K161624 | MicrO2 OSA Device with Micro-Recorder | Microdental, Inc. | 2016 | — |
| −1 | K202529 | ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device… | Prosomnus Sleep Technologies, Inc. | 2020 | — |
| 0 (this device) | K252765 | ProSomnus RPMO2 OSA Device (RPMO2 OSA) | Prosomnus Sleep Technologies | 2026 | — |
| +1 | 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 | 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 PLC? 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 PLC device
- #1 K254304 iNOS intraoral biosensorscore 15.2 · 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 |
|---|---|---|---|
| * | K202529 | ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient…Summary page 5…CFR 880.6310 Product Codes: LRK, LQZ, PLC, DQA, OUG 3. Predicate and Reference Devices Predicate Device: ProSomnus® EVO Sleep and Snore Device with Patient Monitoring (K202529) Reference Device: Oxiband (Checkme™) O2 Pulse Oximeter (K191088) 4. Device Description The ProSomnus® RPMO2 OSA Device is a pre… | 2020 |
| † | K191088 | Checkme O2 Pulse Oximeter | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K254304 | iNOS intraoral biosensor | 2026 | 0 |
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 37 years and passes through 8 companies; a new generation was cleared every 2.6 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K254304 (Achaemenid, LLC, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PLC devicesPLC Sleep Appliances With Patient Monitoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PLC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PLC
Too few PLC 510(k)s in any year since 2007 to give a median.
Recalls per year · PLC
No recall names PLC since 2007.
Adverse event reports per year · PLC
1in 2023
MAUDE reports naming product code PLC, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 2 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The ProSomnus® RPMO2 OSA Device is intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults. Additionally, the fully embedded RPMO2 oximeter sensor measures, displays, stores, and transmits functional oxygen saturation of the arterial hemoglobin (SpO2) and pulse rate. It is intended for continuous data collection during sleep. It can be used in home settings, sleep laboratories, long-term care facilities, and…
Read the full statement (119 words)
The ProSomnus® RPMO2 OSA Device is intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Additionally, the fully embedded RPMO2 oximeter sensor measures, displays, stores, and transmits functional oxygen saturation of the arterial hemoglobin (SpO2) and pulse rate. It is intended for continuous data collection during sleep. It can be used in home settings, sleep laboratories, long-term care facilities, and hospitals.
When used in combination with the ProSomnus® Oxymetrx™ App and ProSomnus® Oxymetrx™ Provider Portal, the device enables remote collection of patients’ physiological data.
The device is intended to be applied in the oral cavity.
The device is intended for use under non-motion conditions in well-perfused areas.
The device is single patient, reusable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252765 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252765: ProSomnus RPMO2 OSA Device (RPMO2 OSA).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252765
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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