510(k) · Cleared
ClearedRemi Custom Night Guard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Grindguard, Inc. · MQC Mouthguard, Prescription
Cleared on Feb 10, 2025 as substantially equivalent to K241369 (Lijia, LLC, 2024) after an 89-day review. Its family tree reaches back 5 generations to 1989.
- Decided
- Feb 10, 2025
- Review
- 89 days
- Class
- Class U
- Product code
- MQC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K882303 (1989). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 4 generations backK014079 DR. Hays Bite GuardInventive Resources, Inc. · 2002
- 3 generations backK121365 Thermoformed MouthguardsGlidewell Laboratories-Sleep Devices Group · 2012
- 2 generations backK210011 JS Dental Lab Mouth GuardAmpower Dental Laboratories, LLC · 2021
- 1 generation backK241369 LIJIA Night GuardLijia, LLC · 2024
- This deviceK243516 Remi Custom Night GuardGrindguard, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −4 | K014079 | DR. Hays Bite Guard | Inventive Resources, Inc. | 2002 | — |
| −3 | K121365 | Thermoformed Mouthguards | Glidewell Laboratories-Sleep Devices Group | 2012 | — |
| −2 | K210011 | JS Dental Lab Mouth Guard | Ampower Dental Laboratories, LLC | 2021 | — |
| −1 | K241369 | LIJIA Night Guard | Lijia, LLC | 2024 | — |
| 0 (this device) | K243516 | Remi Custom Night Guard | Grindguard, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K241369 | LIJIA Night GuardSummary page 5…Mouth Guard Product Code: MQC Device Classification: Unclassified Predicate Device: LIJIA Night Guard (K241369) (Primary Predicate) Reference Device: Thermoforming Sheet Materials (K200125) Device Description: The Remi… | 2024 |
| † | K200125 | Thermoforming Sheet Materials | 2020 |
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 36 years and passes through 6 companies; a new generation was cleared every 8.7 years on median.
- None of the 11 ancestors has a recall.
How does its category compare?
All MQC devicesMQC Mouthguard, Prescription: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Remi Night Guard is indicated for protection of teeth and restorations against grinding and clenching.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243516 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243516: Remi Custom Night Guard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243516
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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