510(k) · Cleared
ClearedNightGuard Aire Max
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nightguard Express, LLC · LRK Device, Anti-Snoring
Cleared on Nov 3, 2025 as substantially equivalent to K232735 (Ema Sleep Incorporated, 2024) after a 68-day review. Its family tree reaches back 14 generations to 1989.
- Decided
- Nov 3, 2025
- Review
- 68 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K882303 (1989). 27 ancestors in all, the oldest K880956 (1988). No later device cites it as a predicate yet.
- Root · 14 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 10 generations between
- 3 generations backK190236 O2Vent OptimaOventus Manufacturing Pty, Ltd. · 2019
- 2 generations backK203606 Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep…Meris Investment Group · 2021
- 1 generation backK232735 EMA 3DEma Sleep Incorporated · 2024
- This deviceK252698 NightGuard Aire MaxNightguard Express, LLC · 2025
Show all 14 generations
- Root · 14 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 13 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 12 generations backK972061 TOAW. Keith Thornton, D.D.S. · 1997
- 11 generations backK022891 The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003
- 10 generations backK030440 Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc. · 2003
- 9 generations backK060388 Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with…Airway Management, Inc. · 2006
- 8 generations backK061732 TAP-TAirway Management, Inc. · 2006
- 7 generations backK103076 DynaflexDyna Flex · 2011
- 6 generations backK160234 OVENTOventus Manufacturing Pty, Ltd. · 2016
- 5 generations backK161832 O2VENT TOventus Manufacturing Pty, Ltd. · 2016
- 4 generations backK171316 O2Vent WOventus Manufacturing Pty, Ltd. · 2017
- 3 generations backK190236 O2Vent OptimaOventus Manufacturing Pty, Ltd. · 2019
- 2 generations backK203606 Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep…Meris Investment Group · 2021
- 1 generation backK232735 EMA 3DEma Sleep Incorporated · 2024
- This deviceK252698 NightGuard Aire MaxNightguard Express, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −13 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −12 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| −11 | K022891 | The Breathe EZ Anti-Snoring Device | D&S Redhage | 2003 | — |
| −10 | K030440 | Oasys-Oral Airway System | Mark Abramson, D.D.S., Inc. | 2003 | — |
| −9 | K060388 | Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment | Airway Management, Inc. | 2006 | — |
| −8 | K061732 | TAP-T | Airway Management, Inc. | 2006 | — |
| −7 | K103076 | Dynaflex | Dyna Flex | 2011 | — |
| −6 | K160234 | OVENT | Oventus Manufacturing Pty, Ltd. | 2016 | — |
| −5 | K161832 | O2VENT T | Oventus Manufacturing Pty, Ltd. | 2016 | — |
| −4 | K171316 | O2Vent W | Oventus Manufacturing Pty, Ltd. | 2017 | — |
| −3 | K190236 | O2Vent Optima | Oventus Manufacturing Pty, Ltd. | 2019 | — |
| −2 | K203606 | Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic… | Meris Investment Group | 2021 | — |
| −1 | K232735 | EMA 3D | Ema Sleep Incorporated | 2024 | — |
| 0 (this device) | K252698 | NightGuard Aire Max | Nightguard Express, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K232735 | EMA 3DSummary page 5…And Obstructive Sleep Apnea Device Class: Class II Classification Panel: Dental Product Code: LRK, LQZ Predicate Device: K232735 - EMA 3D 1… | 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 2.1 years on median.
- None of the 27 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 NightGuard Aire Max is a removable medical device that is fitted in the patient’s mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) 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/K252698 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252698: NightGuard Aire Max.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252698
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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