510(k) · Cleared
ClearedSleepright
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Power Products, Inc.-Splintek · OBR Mouthguard, Over-The-Counter
Cleared on Jun 4, 2010 as substantially equivalent to K071404 (Power Products, Inc.-Splintek, 2007) after a 98-day review. Its family tree reaches back 1 generation to 2007. 30 later devices descend from it.
- Decided
- Jun 4, 2010
- Review
- 98 days
- Class
- Class U
- Product code
- OBR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K071404 (2007). 30 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK071404 Sleep Right - Select, Low Profile and AdvancePower Products, Inc.-Splintek · 2007
- This deviceK100545 SleeprightPower Products, Inc.-Splintek · 2010
- Descendant · cites it directly · 28 of its ownK103004 Snore GuardRanir, LLC · 2011
- Descendant · 2 generations on · 26 of its ownK112205 Snorerx 9.0Consumer Health Products, Inc. · 2011
- Descendant · 3 generations on · 22 of its ownK153200 SnoreRxApnea Sciences Corporation · 2016
- Descendant · 4 generations on · 21 of its ownK170825 SnoreRxApnea Sciences Corporation · 2017
- Descendant · 3 generations on · 4 of its ownK113569 ApnearxApnea Science Corporation · 2012
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K103004Snore GuardRanir, LLC · 2011 · cites it directly28descendants
- K112205Snorerx 9.0Consumer Health Products, Inc. · 2011 · 2 generations on26descendants
- K153200SnoreRxApnea Sciences Corporation · 2016 · 3 generations on22descendants
- K170825SnoreRxApnea Sciences Corporation · 2017 · 4 generations on21descendants
- K113569ApnearxApnea Science Corporation · 2012 · 3 generations on4descendants
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) | K100545 | Sleepright | Power Products, Inc.-Splintek | 2010 | — |
| +1 | K103004 | Snore Guard | Ranir, LLC | 2011 | — |
| +2 | K112205 | Snorerx 9.0 | Consumer Health Products, Inc. | 2011 | — |
| +3 | K153200 | SnoreRx | Apnea Sciences Corporation | 2016 | — |
| +4 | K170825 | SnoreRx | Apnea Sciences Corporation | 2017 | — |
| +3 | K113569 | Apnearx | Apnea Science Corporation | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 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 OBR? 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 OBR device
- #1 K251778 Remi Custom Night Guardscore 15.6 · 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 |
|---|---|---|---|
| * | K071404 | Sleep Right - Select, Low Profile and AdvanceSummary page 2…SleepRight® Original_ SleepRightg -Lo profile~ 510(k) Number K100545 K071404 Device Description: An adjustable protector that An adjustable protector that… | 2007 |
What descends from it? (30)
See all 302 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 OBR devicesOBR Mouthguard, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OBR
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OBR
129in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OBR
No recall names OBR since 2007.
Adverse event reports per year · OBR
13in 2025
MAUDE reports naming product code OBR, 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 | 2 | — | 0 | 1 |
| 2008 | 5 | 55 | 0 | 0 |
| 2009 | 3 | 16 | 0 | 7 |
| 2010 | 2 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 4 | 145 | 0 | 4 |
| 2013 | 2 | — | 0 | 8 |
| 2014 | 2 | — | 0 | 776 |
| 2015 | 1 | — | 0 | 31 |
| 2016 | 1 | — | 0 | 16 |
| 2017 | 1 | — | 0 | 24 |
| 2018 | 2 | — | 0 | 23 |
| 2019 | 3 | 266 | 0 | 29 |
| 2020 | 3 | 161 | 0 | 15 |
| 2021 | 2 | — | 0 | 10 |
| 2022 | 2 | — | 0 | 6 |
| 2023 | 1 | — | 0 | 5 |
| 2024 | 2 | — | 0 | 18 |
| 2025 | 3 | 129 | 0 | 13 |
| 2026 | 4 | 103 | 0 | — |
What is it indicated for?
The SleepRight Original 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/K100545 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100545: Sleepright.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100545
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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