510(k) · Cleared
ClearedEmerald Herbst
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Island Dental Lab, Inc Dba Emerald Dental · LRK Device, Anti-Snoring
Cleared on May 10, 2023 as substantially equivalent to K170692 (Respire Medical Holding, 2017) and 2 other predicates after a 156-day review. Its family tree reaches back 10 generations to 1989.
- Decided
- May 10, 2023
- Review
- 156 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K882303 (1989). 23 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 6 generations between
- 3 generations backK140278 Somnodent Fusion, Classic; Somnodent Fusion, FlexSomnomed, Inc. · 2014
- 2 generations backK150369 SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with…Somnomed, Inc. · 2015
- 1 generation backK170692 Respire Pink Series with DentiTracRespire Medical Holding · 2017
- This deviceK223624 Emerald HerbstIsland Dental Lab, Inc Dba Emerald Dental · 2023
Show all 10 generations
- Root · 10 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 9 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 8 generations backK042161 Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd. · 2004
- 7 generations backK050592 Somnomed Mas RxaSomnomed, Ltd. · 2005
- 6 generations backK073004 Somnomed BflexSomnomed, Inc. · 2008
- 5 generations backK121340 Somnodent G2Somnomed, Inc. · 2012
- 4 generations backK130558 Somnodent Herbst; Classic, FlexSomnomed, Inc. · 2013
- 3 generations backK140278 Somnodent Fusion, Classic; Somnodent Fusion, FlexSomnomed, Inc. · 2014
- 2 generations backK150369 SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with…Somnomed, Inc. · 2015
- 1 generation backK170692 Respire Pink Series with DentiTracRespire Medical Holding · 2017
- This deviceK223624 Emerald HerbstIsland Dental Lab, Inc Dba Emerald Dental · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −9 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −8 | K042161 | Anti-Snoring/Sleep Apnea Device | Rj & VK Bird Pty, Ltd. | 2004 | — |
| −7 | K050592 | Somnomed Mas Rxa | Somnomed, Ltd. | 2005 | — |
| −6 | K073004 | Somnomed Bflex | Somnomed, Inc. | 2008 | — |
| −5 | K121340 | Somnodent G2 | Somnomed, Inc. | 2012 | — |
| −4 | K130558 | Somnodent Herbst; Classic, Flex | Somnomed, Inc. | 2013 | — |
| −3 | K140278 | Somnodent Fusion, Classic; Somnodent Fusion, Flex | Somnomed, Inc. | 2014 | — |
| −2 | K150369 | SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac… | Somnomed, Inc. | 2015 | — |
| −1 | K170692 | Respire Pink Series with DentiTrac | Respire Medical Holding | 2017 | — |
| 0 (this device) | K223624 | Emerald Herbst | Island Dental Lab, Inc Dba Emerald Dental | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2003 | 3 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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? (3)
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 |
|---|---|---|---|
| * | K170692 | Respire Pink Series with DentiTracSummary page 4…apnea (Class II, 21 CFR872.5570, Product Code LRK and LQZ) Primary Predicate Respire Pink Series with DentiTrac(K170692) refers to Herbst ( (K131138), Device Respire Pink Series – Herbst EF (K150572) Reference Device… | 2017 |
| * | K131138 | Respire Pink Series - HerbstSummary page 4…(Class II, 21 CFR872.5570, Product Code LRK and LQZ) Primary Predicate Respire Pink Series with DentiTrac(K170692) refers to Herbst ( (K131138), Device Respire Pink Series – Herbst EF (K150572) Reference Device Dent-O-Cryl Orthodontic A… | 2013 |
| * | K150572 | Respire Pink Series-Herbst-EFSummary page 4…Z) Primary Predicate Respire Pink Series with DentiTrac(K170692) refers to Herbst ( (K131138), Device Respire Pink Series – Herbst EF (K150572) Reference Device Dent-O-Cryl Orthodontic Acrylic (K942667) is used to justify the use… | 2015 |
| † | K942667 | Dent-O-Cryl Orthodontic Acrylic | 1995 |
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 34 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 23 ancestors has a recall of any class.
- 1 other device also cites its predicate K170692.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Emerald Herbst appliance is intended to treat snoring and mild to moderate Obstructive Sleep Apnea (OSA) in adults 18 years of age or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223624 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223624: Emerald Herbst.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223624
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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