510(k) · Cleared
ClearedO2Vent Optima
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oventus Manufacturing Pty, Ltd. · LRK Device, Anti-Snoring
Cleared on Aug 29, 2019 as substantially equivalent to K171316 (Oventus Manufacturing Pty, Ltd., 2017) after a 204-day review. Its family tree reaches back 11 generations to 1989. 5 later devices descend from it.
- Decided
- Aug 29, 2019
- Review
- 204 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K882303 (1989). 20 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 7 generations between
- 3 generations backK160234 OVENTOventus Manufacturing Pty, Ltd. · 2016
- 2 generations backK161832 O2VENT TOventus Manufacturing Pty, Ltd. · 2016
- 1 generation backK171316 O2Vent WOventus Manufacturing Pty, Ltd. · 2017
- This deviceK190236 O2Vent OptimaOventus Manufacturing Pty, Ltd. · 2019
- Descendant · cites it directly · 3 of its ownK203606 Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep…Meris Investment Group · 2021
- Descendant · 2 generations on · 1 of its ownK232735 EMA 3DEma Sleep Incorporated · 2024
- Descendant · 2 generations on · 0 of its ownK252942 ShaeferHShaeferh, LLC · 2026
- Descendant · 3 generations on · 0 of its ownK252698 NightGuard Aire MaxNightguard Express, LLC · 2025
- Descendant · cites it directly · 0 of its ownK220330 Soundly Anti Snoring DeviceGreystone Ip, Ltd. · 2022
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 backK160234 OVENTOventus Manufacturing Pty, Ltd. · 2016
- 2 generations backK161832 O2VENT TOventus Manufacturing Pty, Ltd. · 2016
- 1 generation backK171316 O2Vent WOventus Manufacturing Pty, Ltd. · 2017
- This deviceK190236 O2Vent OptimaOventus Manufacturing Pty, Ltd. · 2019
Most influential descendants
Showing 5 of 5 · See all- K203606Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular…Meris Investment Group · 2021 · cites it directly3descendants
- K232735EMA 3DEma Sleep Incorporated · 2024 · 2 generations on1descendant
- K252942ShaeferHShaeferh, LLC · 2026 · 2 generations on0descendants
- K252698NightGuard Aire MaxNightguard Express, LLC · 2025 · 3 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 |
|---|---|---|---|---|---|
| −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 | K160234 | OVENT | Oventus Manufacturing Pty, Ltd. | 2016 | — |
| −2 | K161832 | O2VENT T | Oventus Manufacturing Pty, Ltd. | 2016 | — |
| −1 | K171316 | O2Vent W | Oventus Manufacturing Pty, Ltd. | 2017 | — |
| 0 (this device) | K190236 | O2Vent Optima | Oventus Manufacturing Pty, Ltd. | 2019 | — |
| +1 | K203606 | Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic… | Meris Investment Group | 2021 | — |
| +2 | K232735 | EMA 3D | Ema Sleep Incorporated | 2024 | — |
| +2 | K252942 | ShaeferH | Shaeferh, LLC | 2026 | — |
| +3 | K252698 | NightGuard Aire Max | Nightguard Express, 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 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 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 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 |
|---|---|---|---|
| * | K171316 | O2Vent WSummary page 4…and obstructive sleep apnea. Classification Code LRK Classification Regulation 21 CFR 872.5570 Device Model Number(s) O2VB Primary Predicate Device K171316 O2Vent W – Oventus Manufacturing Pty Ltd The primary predicate was chosen as it has the same principa… | 2017 |
| † | K143244 | The Panthera Anti-Snoring Device | 2014 |
| † | K971794 | Elastic Mandibular Advancement (Ema) Appliance | 1997 |
What descends from it? (5)
2 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 30 years and passes through 8 companies; a new generation was cleared every 2.1 years on median.
- None of the 20 ancestors has a recall.
- Of its descendants, K203606 (Meris Investment Group, 2021) has gone furthest, with 3 descendants of its own.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 O2Vent Optima 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). The device is indicated for use during sleep to aid in the treatment of these conditions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190236: O2Vent Optima.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190236
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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