510(k) · Cleared
ClearedOravan Herbst
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oravanosa, LLC · LRK Device, Anti-Snoring
Cleared on Oct 29, 2015 as substantially equivalent to K130558 (Somnomed, Inc., 2013) and 1 other predicate after an 87-day review. Its family tree reaches back 7 generations to 1989.
- Decided
- Oct 29, 2015
- Review
- 87 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K882303 (1989). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 6 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 5 generations backK042161 Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd. · 2004
- 4 generations backK050592 Somnomed Mas RxaSomnomed, Ltd. · 2005
- 3 generations backK073004 Somnomed BflexSomnomed, Inc. · 2008
- 2 generations backK121340 Somnodent G2Somnomed, Inc. · 2012
- 1 generation backK130558 Somnodent Herbst; Classic, FlexSomnomed, Inc. · 2013
- This deviceK152159 Oravan HerbstOravanosa, LLC · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −6 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −5 | K042161 | Anti-Snoring/Sleep Apnea Device | Rj & VK Bird Pty, Ltd. | 2004 | — |
| −4 | K050592 | Somnomed Mas Rxa | Somnomed, Ltd. | 2005 | — |
| −3 | K073004 | Somnomed Bflex | Somnomed, Inc. | 2008 | — |
| −2 | K121340 | Somnodent G2 | Somnomed, Inc. | 2012 | — |
| −1 | K130558 | Somnodent Herbst; Classic, Flex | Somnomed, Inc. | 2013 | — |
| 0 (this device) | K152159 | Oravan Herbst | Oravanosa, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K130558 | Somnodent Herbst; Classic, FlexSummary page 5…apnea in adults 5. Predicate Devices: The Oravan Herbst is substantially equivalent to the following devices: i. SomnoDent Herbst (by SomnoMed Inc.), K130558 ii. Oravan OSA (by New Jersey Snoring Solutions), K121285 6. Summary of Similar Technological Characteristics… | 2013 |
| * | K121285 | Oravan OsaSummary page 5…t is substantially equivalent to the following devices: i. SomnoDent Herbst (by SomnoMed Inc.), K130558 ii. Oravan OSA (by New Jersey Snoring Solutions), K121285 6. Summary of Similar Technological Characteristics The proposed 'Oravan Herbst' and the predicate devices are Anti-s… | 2013 |
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 26 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- None of the 10 ancestors has a recall.
- 1 other device also cites its predicate K130558.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Oravan Herbst is intended to reduce snoring and mild to moderate sleep apnea in adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152159 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152159: Oravan Herbst.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152159
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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