510(k) · Cleared
ClearedAsa Oral Appliances
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Sleep Association · LRK Device, Anti-Snoring
Cleared on Oct 18, 2013 as substantially equivalent to K070327 (Sybron Dental Specialties, Inc., 2007) and 2 other predicates after a 233-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.
- Decided
- Oct 18, 2013
- Review
- 233 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K972424 (1997). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK972424 SilentniteGlidewell Laboratories · 1997 · Recalled
- This deviceK130504 Asa Oral AppliancesAmerican Sleep Association · 2013
- Descendant · cites it directly · 1 of its ownK163580 ASD Oral AppliancesAmerican Sleep Dentistry · 2017
- Descendant · 2 generations on · 0 of its ownK190353 Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with…Residential Home Sleep Services · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972424 | Silentnite | Glidewell Laboratories | 1997 | 1 |
| 0 (this device) | K130504 | Asa Oral Appliances | American Sleep Association | 2013 | — |
| +1 | K163580 | ASD Oral Appliances | American Sleep Dentistry | 2017 | — |
| +2 | K190353 | Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac | Residential Home Sleep Services | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 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? (3)
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 |
|---|---|---|---|
| * | K070327 | Removable Arylic Herbst, Allesee Snore Appliance (Asa), and Enoch SnorinatorSummary page 1…snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older. Predicate Devices: Removable Acrylic Herbst (K070327) Hilsen Anti-Snoring Device (K963591) Silent Nite sI (K972424) Technological… | 2007 |
| * | K963591 | Snoring Control DeviceSummary page 1…n adults 18 years of age or older. Predicate Devices: Removable Acrylic Herbst (K070327) Hilsen Anti-Snoring Device (K963591) Silent Nite sI (K972424) Technological The ASA Herbst and HerbstlHilsen Hybrid devices possess… | 1998 |
| * | K972424 | SilentniteSummary page 1…or older. Predicate Devices: Removable Acrylic Herbst (K070327) Hilsen Anti-Snoring Device (K963591) Silent Nite sI (K972424) Technological The ASA Herbst and HerbstlHilsen Hybrid devices possess the same Characteristics: technological c… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163580 | ASD Oral Appliances | 2017 | 1 |
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 LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 ASA Oral Appliances are intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130504 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130504: Asa Oral Appliances.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130504
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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