510(k) · Cleared
ClearedMICR02 Osa Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microdental, Inc. · LRK Device, Anti-Snoring
Cleared on Jul 24, 2014 as substantially equivalent to K050592 (Somnomed, Ltd., 2005) after a 234-day review. Its family tree reaches back 4 generations to 1989. 11 later devices descend from it.
- Decided
- Jul 24, 2014
- Review
- 234 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K882303 (1989). 5 ancestors in all. 11 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 3 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 2 generations backK042161 Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd. · 2004
- 1 generation backK050592 Somnomed Mas RxaSomnomed, Ltd. · 2005
- This deviceK133683 MICR02 Osa DeviceMicrodental, Inc. · 2014
- Descendant · cites it directly · 5 of its ownK161624 MicrO2 OSA Device with Micro-RecorderMicrodental, Inc. · 2016
- Descendant · cites it directly · 3 of its ownK203606 Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep…Meris Investment Group · 2021
- Descendant · cites it directly · 2 of its ownK202529 ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore…Prosomnus Sleep Technologies, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK252765 ProSomnus RPMO2 OSA Device (RPMO2 OSA)Prosomnus Sleep Technologies · 2026
- Descendant · 2 generations on · 1 of its ownK232735 EMA 3DEma Sleep Incorporated · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K161624MicrO2 OSA Device with Micro-RecorderMicrodental, Inc. · 2016 · cites it directly5descendants
- K203606Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular…Meris Investment Group · 2021 · cites it directly3descendants
- K202529ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient…Prosomnus Sleep Technologies, Inc. · 2020 · cites it directly2descendants
- K252765ProSomnus RPMO2 OSA Device (RPMO2 OSA)Prosomnus Sleep Technologies · 2026 · 2 generations on1descendant
- K232735EMA 3DEma Sleep Incorporated · 2024 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −3 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −2 | K042161 | Anti-Snoring/Sleep Apnea Device | Rj & VK Bird Pty, Ltd. | 2004 | — |
| −1 | K050592 | Somnomed Mas Rxa | Somnomed, Ltd. | 2005 | — |
| 0 (this device) | K133683 | MICR02 Osa Device | Microdental, Inc. | 2014 | — |
| +1 | K161624 | MicrO2 OSA Device with Micro-Recorder | Microdental, Inc. | 2016 | — |
| +1 | K203606 | Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic… | Meris Investment Group | 2021 | — |
| +1 | K202529 | ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device… | Prosomnus Sleep Technologies, Inc. | 2020 | — |
| +2 | K252765 | ProSomnus RPMO2 OSA Device (RPMO2 OSA) | Prosomnus Sleep Technologies | 2026 | — |
| +2 | K232735 | EMA 3D | Ema Sleep Incorporated | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K050592 | Somnomed Mas RxaSummary page 1…5. Identification of Predicate Devicelsi Device Name: Somnomed MAS RXA Manufacturer: SomnoMed, Ltd. 510(k) Number: K050592 The predicate device has the same intended use and uses similar materials as the MicrO2 OSA device. 6. Devic… | 2005 |
What descends from it? (11)
See all 115 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161624 | MicrO2 OSA Device with Micro-Recorder | 2016 | 5 |
| K203606 | Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular… | 2021 | 3 |
| K202529 | ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient… | 2020 | 2 |
| K172859 | Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with… | 2017 | 1 |
| K202651 | NOA Sleep Apnea and Snoring Device | 2021 | 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 25 years and passes through 5 companies; a new generation was cleared every 8.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K161624 (Microdental, Inc., 2016) has gone furthest, with 5 descendants of its own.
- 16 other devices also cite its predicate K050592.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 MICRODENTAL, Inc. MicrO2 device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133683 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133683: MICR02 Osa Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133683
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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