510(k) · Cleared
ClearedSomnomed Mas Rxa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Somnomed, Ltd. · LRK Device, Anti-Snoring
Cleared on Jul 12, 2005 as substantially equivalent to K042161 (Rj & VK Bird Pty, Ltd., 2004) after a 126-day review. Its family tree reaches back 3 generations to 1989. 86 later devices descend from it.
- Decided
- Jul 12, 2005
- Review
- 126 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K882303 (1989). 4 ancestors in all. 86 later devices descend from it, 17 citing it directly.
- Root · 3 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 2 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 1 generation backK042161 Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd. · 2004
- This deviceK050592 Somnomed Mas RxaSomnomed, Ltd. · 2005
- Descendant · cites it directly · 32 of its ownK073004 Somnomed BflexSomnomed, Inc. · 2008
- Descendant · cites it directly · 29 of its ownK103076 DynaflexDyna Flex · 2011
- Descendant · 2 generations on · 18 of its ownK121340 Somnodent G2Somnomed, Inc. · 2012
- Descendant · 2 generations on · 17 of its ownK130130 Atg/SM-Osa AppliancesSelane Products, Inc. · 2013
- Descendant · cites it directly · 16 of its ownK130558 Somnodent Herbst; Classic, FlexSomnomed, Inc. · 2013
Showing 5 of 86 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 86 · See all- K073004Somnomed BflexSomnomed, Inc. · 2008 · cites it directly32descendants
- K103076DynaflexDyna Flex · 2011 · cites it directly29descendants
- K121340Somnodent G2Somnomed, Inc. · 2012 · 2 generations on18descendants
- K130130Atg/SM-Osa AppliancesSelane Products, Inc. · 2013 · 2 generations on17descendants
- K130558Somnodent Herbst; Classic, FlexSomnomed, Inc. · 2013 · cites it directly16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −2 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −1 | K042161 | Anti-Snoring/Sleep Apnea Device | Rj & VK Bird Pty, Ltd. | 2004 | — |
| 0 (this device) | K050592 | Somnomed Mas Rxa | Somnomed, Ltd. | 2005 | — |
| +1 | K073004 | Somnomed Bflex | Somnomed, Inc. | 2008 | — |
| +1 | K103076 | Dynaflex | Dyna Flex | 2011 | — |
| +2 | K121340 | Somnodent G2 | Somnomed, Inc. | 2012 | — |
| +2 | K130130 | Atg/SM-Osa Appliances | Selane Products, Inc. | 2013 | — |
| +1 | K130558 | Somnodent Herbst; Classic, Flex | Somnomed, Inc. | 2013 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 7 | 0 |
| 2014 | 7 | 0 |
| 2015 | 6 | 0 |
| 2016 | 6 | 0 |
| 2017 | 7 | 0 |
| 2018 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 5 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K042161 | Anti-Snoring/Sleep Apnea DeviceSummary page 1…A Common Name: Mandibular advancement device Classification Name: Device, anti-snoring (21CFR872.5570]) Product Code: LRK Predicate Device: MDSA K042161 Date Prepared: 3 March 2005 Description Of The Device: The Somnomed MAS RxA is an intraoral device used for treati… | 2004 |
What descends from it? (86)
See all 8617 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073004 | Somnomed Bflex | 2008 | 32 |
| K103076 | Dynaflex | 2011 | 29 |
| K130558 | Somnodent Herbst; Classic, Flex | 2013 | 16 |
| K113201 | Narval CC | 2011 | 15 |
| K140278 | Somnodent Fusion, Classic; Somnodent Fusion, Flex | 2014 | 14 |
| K133683 | MICR02 Osa Device | 2014 | 11 |
| K111207 | Respire Blue Series | 2011 | 11 |
| K171316 | O2Vent W | 2017 | 6 |
| K130067 | Mrna Appliance | 2014 | 5 |
| K153291 | Sicat Optisleep | 2016 | 3 |
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 16 years and passes through 4 companies; a new generation was cleared every 7.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K073004 (Somnomed, Inc., 2008) has gone furthest, with 32 descendants of its own.
- 1 other device also cites its predicate K042161.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 SomnoMed MAS RxA 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/K050592 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050592: Somnomed Mas Rxa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050592
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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