510(k) · Cleared
ClearedZyppah Anti-Snoring Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Always More Marketing · LRK Device, Anti-Snoring
Cleared on Jan 24, 2019 as substantially equivalent to K111680 (Always More Marketing, Inc., 2011) after a 150-day review. Its family tree reaches back 8 generations to 1989. 3 later devices descend from it.
- Decided
- Jan 24, 2019
- Review
- 150 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K882303 (1989). 27 ancestors in all, the oldest K880956 (1988). 3 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 7 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 6 generations backK972061 TOAW. Keith Thornton, D.D.S. · 1997
- 5 generations backK022891 The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003
- 4 generations backK052862 Full Breath Sleep Appliance - AB (Anterior Bite)Bryan Keropian Dds · 2005
- 3 generations backK061228 Full Breath Sleep Appliance with Posterior Tongue DepressorBryan Keropian Dds · 2006
- 2 generations backK091035 Full Breath Sleep Appliance Lower (FBSL)Bryan Keropian Dds · 2009
- 1 generation backK111680 DR. Greensburg's HybridAlways More Marketing, Inc. · 2011
- This deviceK182312 Zyppah Anti-Snoring DeviceAlways More Marketing · 2019
- Descendant · cites it directly · 1 of its ownK252531 Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co. · 2026
- Descendant · 2 generations on · 0 of its ownK261912 SnØreNegatØrDnB Innovations, LLC · 2026
- Descendant · cites it directly · 0 of its ownK203462 Advanced Dental ApplianceDasoft Partners · 2021
Most influential descendants
Showing 3 of 3 · See all- K252531Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)Myofunctional Research Co. · 2026 · cites it directly1descendant
- K261912SnØreNegatØrDnB Innovations, LLC · 2026 · 2 generations on0descendants
- K203462Advanced Dental ApplianceDasoft Partners · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −7 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −6 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| −5 | K022891 | The Breathe EZ Anti-Snoring Device | D&S Redhage | 2003 | — |
| −4 | K052862 | Full Breath Sleep Appliance - AB (Anterior Bite) | Bryan Keropian Dds | 2005 | — |
| −3 | K061228 | Full Breath Sleep Appliance with Posterior Tongue Depressor | Bryan Keropian Dds | 2006 | — |
| −2 | K091035 | Full Breath Sleep Appliance Lower (FBSL) | Bryan Keropian Dds | 2009 | — |
| −1 | K111680 | DR. Greensburg's Hybrid | Always More Marketing, Inc. | 2011 | — |
| 0 (this device) | K182312 | Zyppah Anti-Snoring Device | Always More Marketing | 2019 | — |
| +1 | K252531 | Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) | Myofunctional Research Co. | 2026 | — |
| +2 | K261912 | SnØreNegatØr | DnB Innovations, LLC | 2026 | — |
| +1 | K203462 | Advanced Dental Appliance | Dasoft Partners | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K111680 | DR. Greensburg's HybridSummary page 4…Device, anti-snoring (Class II, 21 CFR 872.5570, Product Code LRK) Predicate Device: Dr. Greenburg’s Hybrid Zyppah (K111680) – Prescription Predicate Reference Predicates: ZQuiet (K180124) – Over the Counter Reference Predicate… | 2011 |
| † | K180124 | ZQuiet | 2018 |
| † | K170825 | SnoreRx | 2017 |
What descends from it? (3)
2 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?
- The line of descent spans 30 years and passes through 7 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 27 ancestors has a recall of any class.
- Of its descendants, K252531 (Myofunctional Research Co., 2026) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K111680.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Zyppah(R) is intended for use by adult patients (18 years or older) as an aid to reduce snoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182312: Zyppah Anti-Snoring Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182312
Report an extraction error
Are you the manufacturer?
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