510(k) · Cleared
ClearedRest Assure System
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 Oct 3, 2024 as substantially equivalent to K150369 (Somnomed, Inc., 2015) and 1 other predicate after a 338-day review. Its family tree reaches back 9 generations to 1989.
- Decided
- Oct 3, 2024
- Review
- 338 days
- Class
- Class II
- Product code
- PLC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K882303 (1989). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 5 generations between
- 3 generations backK130558 Somnodent Herbst; Classic, FlexSomnomed, Inc. · 2013
- 2 generations backK140278 Somnodent Fusion, Classic; Somnodent Fusion, FlexSomnomed, Inc. · 2014
- 1 generation backK150369 SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with…Somnomed, Inc. · 2015
- This deviceK233497 Rest Assure SystemSomnomed, Inc. · 2024
Show all 9 generations
- Root · 9 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 8 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 7 generations backK042161 Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd. · 2004
- 6 generations backK050592 Somnomed Mas RxaSomnomed, Ltd. · 2005
- 5 generations backK073004 Somnomed BflexSomnomed, Inc. · 2008
- 4 generations backK121340 Somnodent G2Somnomed, Inc. · 2012
- 3 generations backK130558 Somnodent Herbst; Classic, FlexSomnomed, Inc. · 2013
- 2 generations backK140278 Somnodent Fusion, Classic; Somnodent Fusion, FlexSomnomed, Inc. · 2014
- 1 generation backK150369 SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with…Somnomed, Inc. · 2015
- This deviceK233497 Rest Assure SystemSomnomed, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −8 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −7 | K042161 | Anti-Snoring/Sleep Apnea Device | Rj & VK Bird Pty, Ltd. | 2004 | — |
| −6 | K050592 | Somnomed Mas Rxa | Somnomed, Ltd. | 2005 | — |
| −5 | K073004 | Somnomed Bflex | Somnomed, Inc. | 2008 | — |
| −4 | K121340 | Somnodent G2 | Somnomed, Inc. | 2012 | — |
| −3 | K130558 | Somnodent Herbst; Classic, Flex | Somnomed, Inc. | 2013 | — |
| −2 | K140278 | Somnodent Fusion, Classic; Somnodent Fusion, Flex | Somnomed, Inc. | 2014 | — |
| −1 | K150369 | SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac… | Somnomed, Inc. | 2015 | — |
| 0 (this device) | K233497 | Rest Assure System | Somnomed, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K150369 | SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac…Summary page 5…acturer Document Predicates Number Rest Assure SomnoDent® Herbst Advance SomnoMed, K150369 System Appliance with Micro- Inc. SomnoDent® Recorder with Micro- Recorder… | 2015 |
| * | K183443 | SomnoDent AvantSummary page 5…iance with Micro- Inc. SomnoDent® Recorder with Micro- Recorder SomnoDent® Avant K183443 The Rest Assure System is substantially equivalent to the SomnoDent® Herbst Advance Appliance with the Micro-Record… | 2019 |
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 35 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- None of the 11 ancestors has a recall.
- 4 other devices also cite its predicate K150369.
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. 2024, 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?
Rest Assure is an intraoral device intended to be used in the treatment of snoring and mild to moderate obstructive sleep apnea in patients over 18. Rest Assure has the capability to record and monitor patient compliance to oral device/appliance therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233497 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233497: Rest Assure System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233497
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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