510(k) · Cleared
ClearedSlow Wave DS8
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Slow Wave, Inc. · LQZ Device, Jaw Repositioning
Cleared on Oct 2, 2020 as substantially equivalent to K192581 (Advanced Facialdontics, LLC, 2020) after a 506-day review. Its family tree reaches back 10 generations to 1989. 5 later devices descend from it.
- Decided
- Oct 2, 2020
- Review
- 506 days
- Class
- Class II
- Product code
- LQZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K882303 (1989). 18 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 6 generations between
- 3 generations backK103076 DynaflexDyna Flex · 2011
- 2 generations backK130130 Atg/SM-Osa AppliancesSelane Products, Inc. · 2013
- 1 generation backK192581 The NightBlocks ApplianceAdvanced Facialdontics, LLC · 2020
- This deviceK191320 Slow Wave DS8Slow Wave, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK233754 AIO BreatheAiomega, LLC · 2024
- Descendant · cites it directly · 1 of its ownK230532 RADx Intraoral Appliance for Snoring and Sleep ApneaAchaemenid, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK254304 iNOS intraoral biosensorAchaemenid, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK252525 AIO BreatheAiomega, LLC · 2025
- Descendant · cites it directly · 0 of its ownK220330 Soundly Anti Snoring DeviceGreystone Ip, Ltd. · 2022
Show all 10 generations
- Root · 10 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 9 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 8 generations backK972061 TOAW. Keith Thornton, D.D.S. · 1997
- 7 generations backK022891 The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003
- 6 generations backK030440 Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc. · 2003
- 5 generations backK060388 Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with…Airway Management, Inc. · 2006
- 4 generations backK061732 TAP-TAirway Management, Inc. · 2006
- 3 generations backK103076 DynaflexDyna Flex · 2011
- 2 generations backK130130 Atg/SM-Osa AppliancesSelane Products, Inc. · 2013
- 1 generation backK192581 The NightBlocks ApplianceAdvanced Facialdontics, LLC · 2020
- This deviceK191320 Slow Wave DS8Slow Wave, Inc. · 2020
Most influential descendants
Showing 5 of 5 · See all- K233754AIO BreatheAiomega, LLC · 2024 · cites it directly1descendant
- K230532RADx Intraoral Appliance for Snoring and Sleep ApneaAchaemenid, LLC · 2023 · cites it directly1descendant
- K254304iNOS intraoral biosensorAchaemenid, LLC · 2026 · 2 generations on0descendants
- K252525AIO BreatheAiomega, LLC · 2025 · 2 generations on0descendants
- K220330Soundly Anti Snoring DeviceGreystone Ip, Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −9 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −8 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| −7 | K022891 | The Breathe EZ Anti-Snoring Device | D&S Redhage | 2003 | — |
| −6 | K030440 | Oasys-Oral Airway System | Mark Abramson, D.D.S., Inc. | 2003 | — |
| −5 | K060388 | Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment | Airway Management, Inc. | 2006 | — |
| −4 | K061732 | TAP-T | Airway Management, Inc. | 2006 | — |
| −3 | K103076 | Dynaflex | Dyna Flex | 2011 | — |
| −2 | K130130 | Atg/SM-Osa Appliances | Selane Products, Inc. | 2013 | — |
| −1 | K192581 | The NightBlocks Appliance | Advanced Facialdontics, LLC | 2020 | — |
| 0 (this device) | K191320 | Slow Wave DS8 | Slow Wave, Inc. | 2020 | — |
| +1 | K233754 | AIO Breathe | Aiomega, LLC | 2024 | — |
| +1 | K230532 | RADx Intraoral Appliance for Snoring and Sleep Apnea | Achaemenid, LLC | 2023 | — |
| +2 | K254304 | iNOS intraoral biosensor | Achaemenid, LLC | 2026 | — |
| +2 | K252525 | AIO Breathe | Aiomega, LLC | 2025 | — |
| +1 | 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 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 LQZ? 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 LQZ device
- #1 K233754 AIO Breathescore 12.9 · 11 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K142344 | FDA’s K142344 is DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System Our reading of the summary gave K142344, FDA’s number for DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation… (Izi Medical Products, LLC). Its FDA name has none of the distinctive words the summary uses for the device it names, “Panthera D-SAD”. Kept off the family tree. Summary page 4…e: Intraoral Devices for Snoring and Intraoral Devices For Snoring And Obstructive Sleep Apnea 510k Number: K142344 Classification: Class II Regulation Number: 21 CFR 872.5570 Product Code: LQZ, LRK… | 2015 |
| * | K192581 | The NightBlocks Appliance Cleared while this submission was under review Summary page 4…e: Intraoral Devices for Snoring and Intraoral Devices For Snoring And Obstructive Sleep Apnea 510k Number: K192581 Classification: Class II Regulation Number: 21 CFR 872.5570 Product Code: LQZ, LRK… | 2020 |
What descends from it? (5)
3 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 31 years and passes through 10 companies; a new generation was cleared every 2.7 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K233754 (Aiomega, LLC, 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LQZ devicesLQZ Device, Jaw Repositioning: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · LQZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LQZ
Too few LQZ 510(k)s in any year since 2007 to give a median.
Recalls per year · LQZ
No recall names LQZ since 2007.
Adverse event reports per year · LQZ
2in 2021
MAUDE reports naming product code LQZ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Intended to reduce or alleviate snoring, mild to moderate Obstructive Sleep Apnea (OSA) while sleeping in adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191320 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191320: Slow Wave DS8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191320
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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