510(k) · Cleared
ClearedSoundly Anti Snoring Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Greystone Ip, Ltd. · LRK Device, Anti-Snoring
Cleared on Sep 8, 2022 as substantially equivalent to K191320 (Slow Wave, Inc., 2020) and 1 other predicate after a 216-day review. Its family tree reaches back 12 generations to 1989.
- Decided
- Sep 8, 2022
- Review
- 216 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K882303 (1989). 24 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 8 generations between
- 3 generations backK161832 O2VENT TOventus Manufacturing Pty, Ltd. · 2016
- 2 generations backK171316 O2Vent WOventus Manufacturing Pty, Ltd. · 2017
- 1 generation backK190236 O2Vent OptimaOventus Manufacturing Pty, Ltd. · 2019
- This deviceK220330 Soundly Anti Snoring DeviceGreystone Ip, Ltd. · 2022
Show all 12 generations
- Root · 12 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 11 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 10 generations backK972061 TOAW. Keith Thornton, D.D.S. · 1997
- 9 generations backK022891 The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003
- 8 generations backK030440 Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc. · 2003
- 7 generations backK060388 Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with…Airway Management, Inc. · 2006
- 6 generations backK061732 TAP-TAirway Management, Inc. · 2006
- 5 generations backK103076 DynaflexDyna Flex · 2011
- 4 generations backK160234 OVENTOventus Manufacturing Pty, Ltd. · 2016
- 3 generations backK161832 O2VENT TOventus Manufacturing Pty, Ltd. · 2016
- 2 generations backK171316 O2Vent WOventus Manufacturing Pty, Ltd. · 2017
- 1 generation backK190236 O2Vent OptimaOventus Manufacturing Pty, Ltd. · 2019
- This deviceK220330 Soundly Anti Snoring DeviceGreystone Ip, Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −11 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −10 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| −9 | K022891 | The Breathe EZ Anti-Snoring Device | D&S Redhage | 2003 | — |
| −8 | K030440 | Oasys-Oral Airway System | Mark Abramson, D.D.S., Inc. | 2003 | — |
| −7 | K060388 | Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment | Airway Management, Inc. | 2006 | — |
| −6 | K061732 | TAP-T | Airway Management, Inc. | 2006 | — |
| −5 | K103076 | Dynaflex | Dyna Flex | 2011 | — |
| −4 | K160234 | OVENT | Oventus Manufacturing Pty, Ltd. | 2016 | — |
| −3 | K161832 | O2VENT T | Oventus Manufacturing Pty, Ltd. | 2016 | — |
| −2 | K171316 | O2Vent W | Oventus Manufacturing Pty, Ltd. | 2017 | — |
| −1 | K190236 | O2Vent Optima | Oventus Manufacturing Pty, Ltd. | 2019 | — |
| 0 (this device) | K220330 | Soundly Anti Snoring Device | Greystone Ip, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2020 | 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? (2)
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 |
|---|---|---|---|
| * | K191320 | Slow Wave DS8Summary page 4…R Reference Mandibular Advancement Device, Product Code: LRK, LQZ CFR Reference: 21 CFR 872.5570 3. PREDICATE DEVICE Primary Predicate device: Slow Wave DS8, K191320. This predicate has not been the subject of a design-related recall. Reference device: O2 Vent Optima, K190236… | 2020 |
| * | K190236 | O2Vent OptimaSummary page 4…TE DEVICE Primary Predicate device: Slow Wave DS8, K191320. This predicate has not been the subject of a design-related recall. Reference device: O2 Vent Optima, K190236 Page 1 of 9 K200321-Summary 4. DEVICE DESCRIPTION The Soundly… | 2019 |
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 33 years and passes through 9 companies; a new generation was cleared every 2.7 years on median.
- None of the 24 ancestors has a recall.
- 2 other devices also cite its predicate K191320.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Soundly Mandibular Advancement Device is intended to reduce or alleviate snoring and mild to moderate
Obstructive Sleep Apnea (OSA) whilst sleeping, in adults
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220330 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220330: Soundly 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/K220330
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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