510(k) · Cleared
ClearedEMA 3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ema Sleep Incorporated · LRK Device, Anti-Snoring
Cleared on May 3, 2024 as substantially equivalent to K203606 (Meris Investment Group, 2021) and 1 other predicate after a 239-day review. Its family tree reaches back 13 generations to 1989. 1 later device descends from it.
- Decided
- May 3, 2024
- Review
- 239 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K882303 (1989). 26 ancestors in all, the oldest K880956 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 9 generations between
- 3 generations backK171316 O2Vent WOventus Manufacturing Pty, Ltd. · 2017
- 2 generations backK190236 O2Vent OptimaOventus Manufacturing Pty, Ltd. · 2019
- 1 generation backK203606 Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep…Meris Investment Group · 2021
- This deviceK232735 EMA 3DEma Sleep Incorporated · 2024
- Descendant · cites it directly · 0 of its ownK252698 NightGuard Aire MaxNightguard Express, LLC · 2025
Show all 13 generations
- Root · 13 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 12 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 11 generations backK972061 TOAW. Keith Thornton, D.D.S. · 1997
- 10 generations backK022891 The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003
- 9 generations backK030440 Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc. · 2003
- 8 generations backK060388 Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with…Airway Management, Inc. · 2006
- 7 generations backK061732 TAP-TAirway Management, Inc. · 2006
- 6 generations backK103076 DynaflexDyna Flex · 2011
- 5 generations backK160234 OVENTOventus Manufacturing Pty, Ltd. · 2016
- 4 generations backK161832 O2VENT TOventus Manufacturing Pty, Ltd. · 2016
- 3 generations backK171316 O2Vent WOventus Manufacturing Pty, Ltd. · 2017
- 2 generations backK190236 O2Vent OptimaOventus Manufacturing Pty, Ltd. · 2019
- 1 generation backK203606 Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep…Meris Investment Group · 2021
- This deviceK232735 EMA 3DEma Sleep Incorporated · 2024
Most influential descendants
Showing 1 of 1 · See all- K252698NightGuard Aire MaxNightguard Express, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −12 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −11 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| −10 | K022891 | The Breathe EZ Anti-Snoring Device | D&S Redhage | 2003 | — |
| −9 | K030440 | Oasys-Oral Airway System | Mark Abramson, D.D.S., Inc. | 2003 | — |
| −8 | K060388 | Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment | Airway Management, Inc. | 2006 | — |
| −7 | K061732 | TAP-T | Airway Management, Inc. | 2006 | — |
| −6 | K103076 | Dynaflex | Dyna Flex | 2011 | — |
| −5 | K160234 | OVENT | Oventus Manufacturing Pty, Ltd. | 2016 | — |
| −4 | K161832 | O2VENT T | Oventus Manufacturing Pty, Ltd. | 2016 | — |
| −3 | K171316 | O2Vent W | Oventus Manufacturing Pty, Ltd. | 2017 | — |
| −2 | K190236 | O2Vent Optima | Oventus Manufacturing Pty, Ltd. | 2019 | — |
| −1 | K203606 | Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic… | Meris Investment Group | 2021 | — |
| 0 (this device) | K232735 | EMA 3D | Ema Sleep Incorporated | 2024 | — |
| +1 | 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 |
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 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 |
|---|---|---|---|
| * | K203606 | Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular…Summary page 6…ive sleep apnea Device Class: Class II Classification Panel: Dental 5. Legally Marketed Predicate Device(s) Primary Predicate K203606 Serena Sleep Elastic Mandibular Advancement Secondary Predicate K971794 Elastic Mandibular Advancement Reference Devic… | 2021 |
| * | K971794 | Elastic Mandibular Advancement (Ema) ApplianceSummary page 6…Panel: Dental 5. Legally Marketed Predicate Device(s) Primary Predicate K203606 Serena Sleep Elastic Mandibular Advancement Secondary Predicate K971794 Elastic Mandibular Advancement Reference Devices K183598 KeySplint Soft K203000 KeySplint Hard 6. Indication for Use S… | 1997 |
| † | K183598 | KeyPrint KeySplint Soft | 2019 |
| † | K203000 | KeyPrint KeySplint Hard | 2021 |
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 |
|---|---|---|---|
| K252698 | NightGuard Aire Max | 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 10 companies; a new generation was cleared every 2.1 years on median.
- None of the 26 ancestors has a recall.
- Of its descendants, K252698 (Nightguard Express, LLC, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K203606.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 EMA 3D 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 as stated in the FDA summary.
https://510kreport.com/device/K232735 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232735: EMA 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232735
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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