510(k) · Cleared
ClearedASD Oral Appliances
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Sleep Dentistry · LRK Device, Anti-Snoring
Cleared on Jun 8, 2017 as substantially equivalent to K130504 (American Sleep Association, 2013) after a 170-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Jun 8, 2017
- Review
- 170 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K972424 (1997). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK972424 SilentniteGlidewell Laboratories · 1997 · Recalled
- 1 generation backK130504 Asa Oral AppliancesAmerican Sleep Association · 2013
- This deviceK163580 ASD Oral AppliancesAmerican Sleep Dentistry · 2017
- Descendant · cites it directly · 0 of its ownK190353 Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with…Residential Home Sleep Services · 2020
Most influential descendants
Showing 1 of 1 · See all- K190353Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTracResidential Home Sleep Services · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972424 | Silentnite | Glidewell Laboratories | 1997 | 1 |
| −1 | K130504 | Asa Oral Appliances | American Sleep Association | 2013 | — |
| 0 (this device) | K163580 | ASD Oral Appliances | American Sleep Dentistry | 2017 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K130504 | Asa Oral AppliancesSummary page 4…to moderate Obstructive Sleep Apnea (OSA) in individuals 18 years of age or older. Primary Predicate Device: American Sleep Association (ASA) Oral Appliances (K130504) Reference Predicate Devices: Removable Acrylic Herbst (K070327) TAP III (K062951) EMA (K971794) === P… | 2013 |
| † | K070327 | Removable Arylic Herbst, Allesee Snore Appliance (Asa), and Enoch Snorinator | 2007 |
| † | K062951 | Tap Iii Anti-Snoring Device | 2006 |
| † | K971794 | Elastic Mandibular Advancement (Ema) Appliance | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190353 | Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac | 2020 | 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?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 16.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K190353 (Residential Home Sleep Services, 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 ASD Oral Appliances are intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in individuals 18 years of age or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163580 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163580: ASD Oral Appliances.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163580
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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