510(k) · Cleared
ClearedAIO Breathe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aiomega, LLC · LRK Device, Anti-Snoring
Cleared on Nov 6, 2025 as substantially equivalent to K233754 (Aiomega, LLC, 2024) after an 87-day review. Its family tree reaches back 12 generations to 1989.
- Decided
- Nov 6, 2025
- Review
- 87 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K882303 (1989). 20 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 backK192581 The NightBlocks ApplianceAdvanced Facialdontics, LLC · 2020
- 2 generations backK191320 Slow Wave DS8Slow Wave, Inc. · 2020
- 1 generation backK233754 AIO BreatheAiomega, LLC · 2024
- This deviceK252525 AIO BreatheAiomega, LLC · 2025
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 backK130130 Atg/SM-Osa AppliancesSelane Products, Inc. · 2013
- 3 generations backK192581 The NightBlocks ApplianceAdvanced Facialdontics, LLC · 2020
- 2 generations backK191320 Slow Wave DS8Slow Wave, Inc. · 2020
- 1 generation backK233754 AIO BreatheAiomega, LLC · 2024
- This deviceK252525 AIO BreatheAiomega, LLC · 2025
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 | K130130 | Atg/SM-Osa Appliances | Selane Products, Inc. | 2013 | — |
| −3 | K192581 | The NightBlocks Appliance | Advanced Facialdontics, LLC | 2020 | — |
| −2 | K191320 | Slow Wave DS8 | Slow Wave, Inc. | 2020 | — |
| −1 | K233754 | AIO Breathe | Aiomega, LLC | 2024 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K233754 | AIO BreatheSummary page 5…obstructive sleep apnea. (21 CFR § 872.5570) Classification Product Code: LQZ, LRK Predicate Device: AIO BREATHE (K233754) Device Description AIO Breathe consists of two separate intraoral trays (upper, lower) that are customized to fit over all the… | 2024 |
| † | K234089 | DNA Appliance | 2024 |
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 36 years and passes through 11 companies; a new generation was cleared every 2.7 years on median.
- None of the 20 ancestors has a recall.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 AIO Breathe is intended to reduce snoring and to treat mild and moderate obstructive sleep apnea in children 6-17 years of age who are diagnosed with snoring and/or mild or moderate obstructive sleep apnea.
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/K252525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252525: AIO Breathe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252525
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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