510(k) · Cleared
ClearedDR. Greensburg's Hybrid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Always More Marketing, Inc. · LRK Device, Anti-Snoring
Cleared on Dec 23, 2011 as substantially equivalent to K020893 (Dennis R. Bailey, Dds, 2002) and 5 other predicates after a 191-day review. Its family tree reaches back 7 generations to 1989. 6 later devices descend from it.
- Decided
- Dec 23, 2011
- Review
- 191 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 7 generations to K882303 (1989). 26 ancestors in all, the oldest K880956 (1988). 6 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 6 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 5 generations backK972061 TOAW. Keith Thornton, D.D.S. · 1997
- 4 generations backK022891 The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003
- 3 generations backK052862 Full Breath Sleep Appliance - AB (Anterior Bite)Bryan Keropian Dds · 2005
- 2 generations backK061228 Full Breath Sleep Appliance with Posterior Tongue DepressorBryan Keropian Dds · 2006
- 1 generation backK091035 Full Breath Sleep Appliance Lower (FBSL)Bryan Keropian Dds · 2009
- This deviceK111680 DR. Greensburg's HybridAlways More Marketing, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK182312 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 · 2 generations on · 0 of its ownK203462 Advanced Dental ApplianceDasoft Partners · 2021
- Descendant · cites it directly · 0 of its ownK120372 DR Greenburgs Hybrid VacuumAlways More Marketing, Inc. · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K182312Zyppah Anti-Snoring DeviceAlways More Marketing · 2019 · cites it directly3descendants
- 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 · 2 generations on0descendants
- K120372DR Greenburgs Hybrid VacuumAlways More Marketing, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −6 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −5 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| −4 | K022891 | The Breathe EZ Anti-Snoring Device | D&S Redhage | 2003 | — |
| −3 | K052862 | Full Breath Sleep Appliance - AB (Anterior Bite) | Bryan Keropian Dds | 2005 | — |
| −2 | K061228 | Full Breath Sleep Appliance with Posterior Tongue Depressor | Bryan Keropian Dds | 2006 | — |
| −1 | K091035 | Full Breath Sleep Appliance Lower (FBSL) | Bryan Keropian Dds | 2009 | — |
| 0 (this device) | K111680 | DR. Greensburg's Hybrid | Always More Marketing, Inc. | 2011 | — |
| +1 | 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 | — |
| +2 | K203462 | Advanced Dental Appliance | Dasoft Partners | 2021 | — |
| +1 | K120372 | DR Greenburgs Hybrid Vacuum | Always More Marketing, Inc. | 2012 | — |
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 |
|---|---|---|
| 2012 | 2 | 0 |
| 2019 | 1 | 0 |
| 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? (6)
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 |
|---|---|---|---|
| * | K020893 | Norad Nocturnal Oral Airway Dilator ApplianceSummary page 1…rg's Hybrid Common or Usual Name: Anti-Snoring and Apnea Device Classification Name: Anti-Snoring Device (21 CFR872.5570) Product Code: LRK Predicate Devices: NoRad (K020893), Vital Sleep (092942), SomnoGuard (K06 1688), Full Breath (K091035), Silent Nite (K972424), EMA (K971794)… | 2002 |
| * | K092942 | Vital SleepSummary page 1…Usual Name: Anti-Snoring and Apnea Device Classification Name: Anti-Snoring Device (21 CFR872.5570) Product Code: LRK Predicate Devices: NoRad (K020893), Vital Sleep (092942), SomnoGuard (K06 1688), Full Breath (K091035), Silent Nite (K972424), EMA (K971794)… | 2010 |
| * | K061688 | Anti-Snoring / Sleep Apnea DeviceSummary page 1…ing and Apnea Device Classification Name: Anti-Snoring Device (21 CFR872.5570) Product Code: LRK Predicate Devices: NoRad (K020893), Vital Sleep (092942), SomnoGuard (K06 1688), Full Breath (K091035), Silent Nite (K972424), EMA (K971794) Always More Mar… | 2006 |
| * | K091035 | Full Breath Sleep Appliance Lower (FBSL)Summary page 1…assification Name: Anti-Snoring Device (21 CFR872.5570) Product Code: LRK Predicate Devices: NoRad (K020893), Vital Sleep (092942), SomnoGuard (K06 1688), Full Breath (K091035), Silent Nite (K972424), EMA (K971794) Always More Marketing Inc… | 2009 |
| * | K972424 | SilentniteSummary page 1…-Snoring Device (21 CFR872.5570) Product Code: LRK Predicate Devices: NoRad (K020893), Vital Sleep (092942), SomnoGuard (K06 1688), Full Breath (K091035), Silent Nite (K972424), EMA (K971794) Always More Marketing Inc… | 1997 |
| * | K971794 | Elastic Mandibular Advancement (Ema) ApplianceSummary page 1…(21 CFR872.5570) Product Code: LRK Predicate Devices: NoRad (K020893), Vital Sleep (092942), SomnoGuard (K06 1688), Full Breath (K091035), Silent Nite (K972424), EMA (K971794) Always More Marketing Inc 45 35 W. Sahara… | 1997 |
What descends from it? (6)
4 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 22 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 26 ancestors has a recall of any class.
- Of its descendants, K182312 (Always More Marketing, 2019) has gone furthest, with 3 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. 2011, 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 Dr Greenburg's Hybrid Snoring Device is indicated for persons 18 years or older, who wish to reduce the incidence of snoring and/or mild to moderate obstructive sleep apnea
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111680 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111680: DR. Greensburg's Hybrid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111680
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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