510(k) · Cleared
ClearedSomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Somnomed, Inc. · PLC Sleep Appliances With Patient Monitoring
Cleared on Jun 18, 2015 as substantially equivalent to K140278 (Somnomed, Inc., 2014) after a 125-day review. Its family tree reaches back 8 generations to 1989. 12 later devices descend from it.
- Decided
- Jun 18, 2015
- Review
- 125 days
- Class
- Class II
- Product code
- PLC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K882303 (1989). 9 ancestors in all. 12 later devices descend from it, 5 citing it directly.
- Root · 8 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 7 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 6 generations backK042161 Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd. · 2004
- 5 generations backK050592 Somnomed Mas RxaSomnomed, Ltd. · 2005
- 4 generations backK073004 Somnomed BflexSomnomed, Inc. · 2008
- 3 generations backK121340 Somnodent G2Somnomed, Inc. · 2012
- 2 generations backK130558 Somnodent Herbst; Classic, FlexSomnomed, Inc. · 2013
- 1 generation backK140278 Somnodent Fusion, Classic; Somnodent Fusion, FlexSomnomed, Inc. · 2014
- This deviceK150369 SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with…Somnomed, Inc. · 2015
- Descendant · cites it directly · 5 of its ownK161624 MicrO2 OSA Device with Micro-RecorderMicrodental, Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK202529 ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore…Prosomnus Sleep Technologies, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK170692 Respire Pink Series with DentiTracRespire Medical Holding · 2017
- Descendant · 3 generations on · 1 of its ownK252765 ProSomnus RPMO2 OSA Device (RPMO2 OSA)Prosomnus Sleep Technologies · 2026
- Descendant · 2 generations on · 1 of its ownK172859 Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and…Prosomnous Sleep Technologies · 2017
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K161624MicrO2 OSA Device with Micro-RecorderMicrodental, Inc. · 2016 · cites it directly5descendants
- K202529ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient…Prosomnus Sleep Technologies, Inc. · 2020 · 2 generations on2descendants
- K170692Respire Pink Series with DentiTracRespire Medical Holding · 2017 · cites it directly2descendants
- K252765ProSomnus RPMO2 OSA Device (RPMO2 OSA)Prosomnus Sleep Technologies · 2026 · 3 generations on1descendant
- K172859Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with…Prosomnous Sleep Technologies · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −7 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −6 | K042161 | Anti-Snoring/Sleep Apnea Device | Rj & VK Bird Pty, Ltd. | 2004 | — |
| −5 | K050592 | Somnomed Mas Rxa | Somnomed, Ltd. | 2005 | — |
| −4 | K073004 | Somnomed Bflex | Somnomed, Inc. | 2008 | — |
| −3 | K121340 | Somnodent G2 | Somnomed, Inc. | 2012 | — |
| −2 | K130558 | Somnodent Herbst; Classic, Flex | Somnomed, Inc. | 2013 | — |
| −1 | K140278 | Somnodent Fusion, Classic; Somnodent Fusion, Flex | Somnomed, Inc. | 2014 | — |
| 0 (this device) | 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 | — |
| +2 | K202529 | ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device… | Prosomnus Sleep Technologies, Inc. | 2020 | — |
| +1 | K170692 | Respire Pink Series with DentiTrac | Respire Medical Holding | 2017 | — |
| +3 | K252765 | ProSomnus RPMO2 OSA Device (RPMO2 OSA) | Prosomnus Sleep Technologies | 2026 | — |
| +2 | K172859 | Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore… | Prosomnous Sleep Technologies | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K140278 | Somnodent Fusion, Classic; Somnodent Fusion, FlexSummary page 4…Number ® SomnoDent® with SomnoDent Fusion Classic, SomnoMed, Inc. K140278 Micro-Recorder SomnoDent® Fusion Flex The SomnoDent® with Micro-Recorder is substantially equivalent to the S… | 2014 |
What descends from it? (12)
See all 125 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 26 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K161624 (Microdental, Inc., 2016) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K140278.
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. 2015, 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 SomnoDent® intraoral devices are intended for the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.
Optionally, if the DentiTrac® micro-recorder is completely embedded into the SomnoDent® appliance, the micro-recorder is intended to measure patient compliance to oral appliance therapy in combination with the DentiTrac® System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150369 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150369: SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac 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/K150369
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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