510(k) · Cleared
ClearedAIO Breathe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aiomega, LLC · LQZ Device, Jaw Repositioning
Cleared on Feb 23, 2024 as substantially equivalent to K191320 (Slow Wave, Inc., 2020) after a 93-day review. Its family tree reaches back 11 generations to 1989. 1 later device descends from it.
- Decided
- Feb 23, 2024
- Review
- 93 days
- Class
- Class II
- Product code
- LQZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K882303 (1989). 19 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 7 generations between
- 3 generations backK130130 Atg/SM-Osa AppliancesSelane Products, Inc. · 2013
- 2 generations backK192581 The NightBlocks ApplianceAdvanced Facialdontics, LLC · 2020
- 1 generation backK191320 Slow Wave DS8Slow Wave, Inc. · 2020
- This deviceK233754 AIO BreatheAiomega, LLC · 2024
- Descendant · cites it directly · 0 of its ownK252525 AIO BreatheAiomega, LLC · 2025
Show all 11 generations
- Root · 11 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 10 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 9 generations backK972061 TOAW. Keith Thornton, D.D.S. · 1997
- 8 generations backK022891 The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003
- 7 generations backK030440 Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc. · 2003
- 6 generations backK060388 Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with…Airway Management, Inc. · 2006
- 5 generations backK061732 TAP-TAirway Management, Inc. · 2006
- 4 generations backK103076 DynaflexDyna Flex · 2011
- 3 generations backK130130 Atg/SM-Osa AppliancesSelane Products, Inc. · 2013
- 2 generations backK192581 The NightBlocks ApplianceAdvanced Facialdontics, LLC · 2020
- 1 generation backK191320 Slow Wave DS8Slow Wave, Inc. · 2020
- This deviceK233754 AIO BreatheAiomega, LLC · 2024
Most influential descendants
Showing 1 of 1 · See all- K252525AIO BreatheAiomega, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −10 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −9 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| −8 | K022891 | The Breathe EZ Anti-Snoring Device | D&S Redhage | 2003 | — |
| −7 | K030440 | Oasys-Oral Airway System | Mark Abramson, D.D.S., Inc. | 2003 | — |
| −6 | K060388 | Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment | Airway Management, Inc. | 2006 | — |
| −5 | K061732 | TAP-T | Airway Management, Inc. | 2006 | — |
| −4 | K103076 | Dynaflex | Dyna Flex | 2011 | — |
| −3 | K130130 | Atg/SM-Osa Appliances | Selane Products, Inc. | 2013 | — |
| −2 | K192581 | The NightBlocks Appliance | Advanced Facialdontics, LLC | 2020 | — |
| −1 | K191320 | Slow Wave DS8 | Slow Wave, Inc. | 2020 | — |
| 0 (this device) | K233754 | AIO Breathe | Aiomega, LLC | 2024 | — |
| +1 | K252525 | AIO Breathe | Aiomega, LLC | 2025 | — |
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 |
|---|---|---|
| 2025 | 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 K191320 Slow Wave DS8score 11.8 · 10 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 |
|---|---|---|---|
| * | K191320 | Slow Wave DS8Summary page 5…Class II Regulation Number: 21 CFR 872.5570 Classification Product Code: LQZ, LRK Predicate Device: Slow Wave DS8 (K191320) Device Description AIO Breathe consists of two separate intraoral trays (upper, lower) that are customized to fit over all the… | 2020 |
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 |
|---|---|---|---|
| K252525 | AIO Breathe | 2025 | 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 35 years and passes through 11 companies; a new generation was cleared every 2.7 years on median.
- None of the 19 ancestors has a recall.
- Of its descendants, K252525 (Aiomega, LLC, 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K191320.
How does its category compare?
All LQZ devicesLQZ Device, Jaw Repositioning: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K233754 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233754: AIO Breathe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233754
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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