510(k) · Cleared
ClearedMandibular Advancement Device L07
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dcstar, Inc. · LRK Device, Anti-Snoring
Cleared on Oct 22, 2025 as substantially equivalent to K170825 (Apnea Sciences Corporation, 2017) after a 147-day review. Its family tree reaches back 6 generations to 2007.
- Decided
- Oct 22, 2025
- Review
- 147 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K071404 (2007). 11 ancestors in all, the oldest K882303 (1989). No later device cites it as a predicate yet.
- Root · 6 generations backK071404 Sleep Right - Select, Low Profile and AdvancePower Products, Inc.-Splintek · 2007
- 5 generations backK100545 SleeprightPower Products, Inc.-Splintek · 2010
- 4 generations backK103004 Snore GuardRanir, LLC · 2011
- 3 generations backK112205 Snorerx 9.0Consumer Health Products, Inc. · 2011
- 2 generations backK153200 SnoreRxApnea Sciences Corporation · 2016
- 1 generation backK170825 SnoreRxApnea Sciences Corporation · 2017
- This deviceK251628 Mandibular Advancement Device L07Dcstar, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K071404 | Sleep Right - Select, Low Profile and Advance | Power Products, Inc.-Splintek | 2007 | — |
| −5 | K100545 | Sleepright | Power Products, Inc.-Splintek | 2010 | — |
| −4 | K103004 | Snore Guard | Ranir, LLC | 2011 | — |
| −3 | K112205 | Snorerx 9.0 | Consumer Health Products, Inc. | 2011 | — |
| −2 | K153200 | SnoreRx | Apnea Sciences Corporation | 2016 | — |
| −1 | K170825 | SnoreRx | Apnea Sciences Corporation | 2017 | — |
| 0 (this device) | K251628 | Mandibular Advancement Device L07 | Dcstar, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 1 | 0 |
| 2010 | 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 LRK? 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 LRK device
- #1 K252531 Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for…score 16.3 · 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 |
|---|---|---|---|
| * | K170825 | SnoreRxSummary page 5…ces For Snoring And Obstructive Sleep Apnea Production code: LRK Regulation number: 21 CFR 872.5570 Classification: Class II Predicate Device Information 510(k) Number: K170825 Manufacturer: Apnea Sciences Corporation Device Name: SnoreRx Device Class: Class II Product Code: LRK Regulation Number: 21 CFR… | 2017 |
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 18 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- None of the 11 ancestors has a recall.
- 10 other devices also cite its predicate K170825.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · LRK
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LRK
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LRK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LRK
653in 2025
MAUDE reports naming product code LRK, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 109 | 0 | 1 |
| 2009 | 3 | 88 | 2 | 11 |
| 2010 | 8 | 195 | 0 | 7 |
| 2011 | 10 | 134 | 0 | 69 |
| 2012 | 10 | 142 | 0 | 445 |
| 2013 | 9 | 233 | 0 | 72 |
| 2014 | 11 | 219 | 0 | 49 |
| 2015 | 6 | 117 | 0 | 28 |
| 2016 | 10 | 157 | 0 | 18 |
| 2017 | 7 | 170 | 0 | 32 |
| 2018 | 10 | 200 | 0 | 61 |
| 2019 | 13 | 150 | 0 | 56 |
| 2020 | 5 | 80 | 0 | 24 |
| 2021 | 10 | 126 | 0 | 49 |
| 2022 | 11 | 154 | 0 | 40 |
| 2023 | 5 | 156 | 0 | 50 |
| 2024 | 6 | 254 | 0 | 185 |
| 2025 | 14 | 107 | 1 | 653 |
| 2026 | 10 | 63 | 1 | — |
What is it indicated for?
The Mandibular Advancement Device is designed to advance the user's lower jaw and maintain this position during use, opening the airway to reduce snoring during sleep. It is intended for adults with at least 18 years old.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251628 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251628: Mandibular Advancement Device L07.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251628
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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