510(k) · Cleared
ClearedProsomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prosomnous Sleep Technologies · PLC Sleep Appliances With Patient Monitoring
Cleared on Nov 22, 2017 as substantially equivalent to K133683 (Microdental, Inc., 2014) and 1 other predicate after a 63-day review. Its family tree reaches back 10 generations to 1989. 1 later device descends from it.
- Decided
- Nov 22, 2017
- Review
- 63 days
- Class
- Class II
- Product code
- PLC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K882303 (1989). 12 ancestors in all. 1 later device descends 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 deviceK172859 Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and…Prosomnous Sleep Technologies · 2017
- Descendant · cites it directly · 0 of its ownK190687 Twilite ApplianceStephen J Harkins, Dds, PC · 2019
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 deviceK172859 Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and…Prosomnous Sleep Technologies · 2017
Most influential descendants
Showing 1 of 1 · See all- K190687Twilite ApplianceStephen J Harkins, Dds, PC · 2019 · cites it directly0descendants
View 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) | K172859 | Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore… | Prosomnous Sleep Technologies | 2017 | — |
| +1 | K190687 | Twilite Appliance | Stephen J Harkins, Dds, PC | 2019 | — |
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 |
|---|---|---|
| 2019 | 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 K252765 ProSomnus RPMO2 OSA Device (RPMO2 OSA)score 17.1 · 11 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 5…Product Code: LRK (Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.) 6. Primary Predicate: MicrO2 OSA Device K133683 Reference Device: SomnoDent Fusion K140278 Reference Device: Narval CC K113201 7. Product Description: The P… | 2014 |
| * | K161624 | MicrO2 OSA Device with Micro-RecorderSummary page 8…devices for snoring and obstructive sleep apnea with patient compliance monitoring.) 6. Primary Predicate: MicrO2 Sleep and Snore Device with Micro-recorder K161624 Reference Device: SomnoDent (Fusion) with Micro Recorder K150369 Reference Device: Narval CC K113201 7. Prod… | 2016 |
| † | K140278 | Somnodent Fusion, Classic; Somnodent Fusion, Flex | 2014 |
| † | K113201 | Narval CC | 2011 |
| † | K150369 | SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac… | 2015 |
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 |
|---|---|---|---|
| K190687 | Twilite Appliance | 2019 | 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 28 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K190687 (Stephen J Harkins, Dds, PC, 2019) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K133683.
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. 2017, 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 [CA] Sleep and Snore Device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
The Prosomnus [CA] Sleep and Snore Device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
The DentiTrac® micro-recorder is completely embedded into the Prosomnus [CA] Sleep and Snore appliance. The micro-recorder is intended to measure patient compliance to the oral appliance therapy in combination with the DentiTrac® System..
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172859 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172859: Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172859
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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