510(k) · Cleared
ClearedTwilite Appliance
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stephen J Harkins, Dds, PC · LRK Device, Anti-Snoring
Cleared on Jul 2, 2019 as substantially equivalent to K172859 (Prosomnous Sleep Technologies, 2017) after a 106-day review. Its family tree reaches back 11 generations to 1989.
- Decided
- Jul 2, 2019
- Review
- 106 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K882303 (1989). 13 ancestors in all. No later device cites it as a predicate yet.
- 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 backK172859 Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and…Prosomnous Sleep Technologies · 2017
- This deviceK190687 Twilite ApplianceStephen J Harkins, Dds, PC · 2019
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 backK172859 Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and…Prosomnous Sleep Technologies · 2017
- This deviceK190687 Twilite ApplianceStephen J Harkins, Dds, PC · 2019
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 | K172859 | Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore… | Prosomnous Sleep Technologies | 2017 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K172859 | Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with…Summary page 4…intraoral devices for snoring and obstructive sleep apnea 21 CFR 872.5570, Class 2 Primary Predicate: K172859 - Prosomnus [CA] Sleep and Snore Device Reference Device: K153490 – Dental Direkt – DD Biosplint P Device Des… | 2017 |
| † | K153490 | DD medical polymers | 2016 |
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 30 years and passes through 8 companies; a new generation was cleared every 1.4 years on median.
- None of the 13 ancestors has a recall.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Twilite Appliance ® is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190687 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190687: Twilite Appliance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190687
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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