510(k) · Cleared
ClearedSleep Right - Select, Low Profile and Advance
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Power Products, Inc.-Splintek · MQC Mouthguard, Prescription
Cleared on Aug 17, 2007 after an 88-day review. The FDA summary names its predicate without a number. 52 later devices descend from it.
- Decided
- Aug 17, 2007
- Review
- 88 days
- Class
- Class U
- Product code
- MQC
- Recalls
- None
- Predicates
- 0
52 later devices descend from it, 9 citing it directly.
- This deviceK071404 Sleep Right - Select, Low Profile and AdvancePower Products, Inc.-Splintek · 2007
- Descendant · cites it directly · 30 of its ownK100545 SleeprightPower Products, Inc.-Splintek · 2010
- Descendant · 2 generations on · 28 of its ownK103004 Snore GuardRanir, LLC · 2011
- Descendant · 3 generations on · 26 of its ownK112205 Snorerx 9.0Consumer Health Products, Inc. · 2011
- Descendant · 4 generations on · 22 of its ownK153200 SnoreRxApnea Sciences Corporation · 2016
- Descendant · 5 generations on · 21 of its ownK170825 SnoreRxApnea Sciences Corporation · 2017
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K100545SleeprightPower Products, Inc.-Splintek · 2010 · cites it directly30descendants
- K103004Snore GuardRanir, LLC · 2011 · 2 generations on28descendants
- K112205Snorerx 9.0Consumer Health Products, Inc. · 2011 · 3 generations on26descendants
- K153200SnoreRxApnea Sciences Corporation · 2016 · 4 generations on22descendants
- K170825SnoreRxApnea Sciences Corporation · 2017 · 5 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071404 | Sleep Right - Select, Low Profile and Advance | Power Products, Inc.-Splintek | 2007 | — |
| +1 | K100545 | Sleepright | Power Products, Inc.-Splintek | 2010 | — |
| +2 | K103004 | Snore Guard | Ranir, LLC | 2011 | — |
| +3 | K112205 | Snorerx 9.0 | Consumer Health Products, Inc. | 2011 | — |
| +4 | K153200 | SnoreRx | Apnea Sciences Corporation | 2016 | — |
| +5 | K170825 | SnoreRx | Apnea Sciences Corporation | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 5 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 5 | 0 |
| 2025 | 9 | 0 |
| 2026 | 7 | 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? (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 |
|---|---|---|---|
| * | — | EZ Splint Named without a submission number | |
| * | — | The Doctor's® NightGuard Named without a submission number |
What descends from it? (52)
See all 529 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100545 | Sleepright | 2010 | 30 |
| K110468 | Freeway Comfort Bite Guard | 2011 | 10 |
| K123161 | Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard… | 2013 | 9 |
| K172223 | SleepRight ProRx Custom Dental Guard | 2017 | 3 |
| K112879 | Rest Assured Ready to Wear Nite Protector | 2012 | 2 |
| K212767 | SleepRight Select-Comfort Dental Guard | 2021 | 0 |
| K123849 | New Comfort-Fit Dental Guard | 2013 | 0 |
| K090472 | Grind Guard | 2009 | 0 |
| K072968 | Stressgard Nightguard | 2008 | 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?
- Of its descendants, K100545 (Power Products, Inc.-Splintek, 2010) has gone furthest, with 30 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. 2007, 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 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.
The SleepRight® adjustable night guard is indicated for the 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071404 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071404: Sleep Right - Select, Low Profile and Advance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071404
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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