510(k) · Cleared
ClearedFreeway Comfort Bite Guard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randmark Dental Products, LLC · MQC Mouthguard, Prescription
Cleared on Aug 5, 2011 as substantially equivalent to K071404 (Power Products, Inc.-Splintek, 2007) after a 169-day review. Its family tree reaches back 1 generation to 2007. 10 later devices descend from it.
- Decided
- Aug 5, 2011
- Review
- 169 days
- Class
- Class U
- Product code
- MQC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K071404 (2007). 10 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK071404 Sleep Right - Select, Low Profile and AdvancePower Products, Inc.-Splintek · 2007
- This deviceK110468 Freeway Comfort Bite GuardRandmark Dental Products, LLC · 2011
- Descendant · cites it directly · 9 of its ownK123161 Smartguard Night Guard, Smartguard Original, Smartguard Night Guard…Smartguard, Inc. · 2013
- Descendant · 2 generations on · 6 of its ownK133037 GrindguardGrind Guard Technologies, LLC · 2014
- Descendant · 3 generations on · 5 of its ownK181099 Bright GuardKoncept Innovators, LLC · 2019
- Descendant · 4 generations on · 3 of its ownK221369 FBCC Night GuardFbcc, Inc. · 2022
- Descendant · 5 generations on · 1 of its ownK251778 Remi Custom Night GuardRemi · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K123161Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard…Smartguard, Inc. · 2013 · cites it directly9descendants
- K133037GrindguardGrind Guard Technologies, LLC · 2014 · 2 generations on6descendants
- K181099Bright GuardKoncept Innovators, LLC · 2019 · 3 generations on5descendants
- K221369FBCC Night GuardFbcc, Inc. · 2022 · 4 generations on3descendants
- K251778Remi Custom Night GuardRemi · 2025 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K071404 | Sleep Right - Select, Low Profile and Advance | Power Products, Inc.-Splintek | 2007 | — |
| 0 (this device) | K110468 | Freeway Comfort Bite Guard | Randmark Dental Products, LLC | 2011 | — |
| +1 | K123161 | Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original… | Smartguard, Inc. | 2013 | — |
| +2 | K133037 | Grindguard | Grind Guard Technologies, LLC | 2014 | — |
| +3 | K181099 | Bright Guard | Koncept Innovators, LLC | 2019 | — |
| +4 | K221369 | FBCC Night Guard | Fbcc, Inc. | 2022 | — |
| +5 | K251778 | Remi Custom Night Guard | Remi | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 15.4 · 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071404 | Sleep Right - Select, Low Profile and AdvanceSummary page 3…2 5.6 PREDICATE DEVICES 5.61 Predicate Devices: SleepRight 0Products listed below (K071404) (Applicant: Power Products, Inc. - Splintek)… | 2007 |
| Kept off the family tree | K010876 | FDA’s K010876 is Nti Tension Suppression System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2001 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123161 | Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard… | 2013 | 9 |
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?
How does its category compare?
All MQC devicesMQC Mouthguard, Prescription: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
Protection against teeth grinding, bruxism and jaw clenching.
Short-term pain relief from muscle spasm due to occlusal interference.
For the prevention of chronic tension and temporomandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110468 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110468: Freeway Comfort Bite Guard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110468
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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