510(k) · Cleared
ClearedSerena Sleep Night Guard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meris Investment Group · MQC Mouthguard, Prescription
Cleared on Oct 13, 2023 as substantially equivalent to K203596 (Panthera Dental, Inc., 2021) after a 232-day review. Its family tree reaches back 7 generations to 1989. 1 later device descends from it.
- Decided
- Oct 13, 2023
- Review
- 232 days
- Class
- Class U
- Product code
- MQC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K882303 (1989). 21 ancestors in all, the oldest K880956 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 6 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 5 generations backK042161 Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd. · 2004
- 4 generations backK050592 Somnomed Mas RxaSomnomed, Ltd. · 2005
- 3 generations backK113201 Narval CCResmed Sas · 2011
- 2 generations backK143244 The Panthera Anti-Snoring DevicePanthera Dental, Inc. · 2014
- 1 generation backK203596 Panthera Occlusal AppliancePanthera Dental, Inc. · 2021
- This deviceK230495 Serena Sleep Night GuardMeris Investment Group · 2023
- Descendant · cites it directly · 0 of its ownK230548 Myoaligner ApplianceMyohealth Technologies, LLC · 2024
Most influential descendants
Showing 1 of 1 · See all- K230548Myoaligner ApplianceMyohealth Technologies, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −6 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −5 | K042161 | Anti-Snoring/Sleep Apnea Device | Rj & VK Bird Pty, Ltd. | 2004 | — |
| −4 | K050592 | Somnomed Mas Rxa | Somnomed, Ltd. | 2005 | — |
| −3 | K113201 | Narval CC | Resmed Sas | 2011 | — |
| −2 | K143244 | The Panthera Anti-Snoring Device | Panthera Dental, Inc. | 2014 | — |
| −1 | K203596 | Panthera Occlusal Appliance | Panthera Dental, Inc. | 2021 | — |
| 0 (this device) | K230495 | Serena Sleep Night Guard | Meris Investment Group | 2023 | — |
| +1 | K230548 | Myoaligner Appliance | Myohealth Technologies, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2011 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 MQC? 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 MQC device
- #1 K203000 KeyPrint KeySplint Hardscore 15.3 · 5 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 |
|---|---|---|---|
| * | K203596 | Panthera Occlusal ApplianceSummary page 5…MQC Subsequent Product OCO Code: Device Classification: Unclassified Predicate Device: Panthera Occlusal Appliance (K203596) Device Description: The Serena Sleep Night Guard/Occlusal Appliance is a custom-made intraoral device used for protecting… | 2021 |
| † | K143244 | The Panthera Anti-Snoring Device | 2014 |
| † | K203606 | Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular… | 2021 |
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 |
|---|---|---|---|
| K230548 | Myoaligner Appliance | 2024 | 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 34 years and passes through 7 companies; a new generation was cleared every 6.3 years on median.
- None of the 21 ancestors has a recall.
- Of its descendants, K230548 (Myohealth Technologies, LLC, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MQC devicesMQC Mouthguard, Prescription: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MQC
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQC
185in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQC
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQC
7in 2025
MAUDE reports naming product code MQC, 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 | 4 | 79 | 0 | 9 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 4 | 194 | 0 | 2 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 6 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 3 | 234 | 0 | 5 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 2 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 71 |
| 2019 | 5 | 286 | 0 | 62 |
| 2020 | 4 | 204 | 0 | 46 |
| 2021 | 7 | 158 | 0 | 111 |
| 2022 | 5 | 120 | 0 | 137 |
| 2023 | 6 | 230 | 1 | 62 |
| 2024 | 8 | 249 | 0 | 8 |
| 2025 | 4 | 185 | 0 | 7 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Serena Sleep Night Guard/Occlusal Appliance is a removable medical device that is fitted to the patient’s mouth and is intended to protect teeth and restorations against the forces of bruxism and alleviate temporomandibular joint, jaw, and muscle and tension headache pains.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230495 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230495: Serena Sleep Night Guard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230495
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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