510(k) · Cleared
ClearedAcrylic Herbst Appliance
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Embassy Dental Laboratory · LRK Device, Anti-Snoring
Cleared on Jul 22, 2011 as substantially equivalent to K070327 (Sybron Dental Specialties, Inc., 2007) and 2 other predicates after a 102-day review. Its family tree reaches back 8 generations to 1989. 3 later devices descend from it.
- Decided
- Jul 22, 2011
- Review
- 102 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K882303 (1989). 16 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 7 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 6 generations backK972061 TOAW. Keith Thornton, D.D.S. · 1997
- 5 generations backK022891 The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003
- 4 generations backK030440 Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc. · 2003
- 3 generations backK060388 Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with…Airway Management, Inc. · 2006
- 2 generations backK061732 TAP-TAirway Management, Inc. · 2006
- 1 generation backK103076 DynaflexDyna Flex · 2011
- This deviceK111009 Acrylic Herbst ApplianceEmbassy Dental Laboratory · 2011
- Descendant · cites it directly · 2 of its ownK113126 Acrylic Herbst ApplianceGergens Orthodontic Lab · 2013
- Descendant · 2 generations on · 0 of its ownK170578 True Function Adjustable Herbst AppliancesTrue Function Laboratory, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK143591 Dorsal ApplianceGergens Orthodontic Lab · 2015
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −7 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −6 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| −5 | K022891 | The Breathe EZ Anti-Snoring Device | D&S Redhage | 2003 | — |
| −4 | K030440 | Oasys-Oral Airway System | Mark Abramson, D.D.S., Inc. | 2003 | — |
| −3 | K060388 | Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment | Airway Management, Inc. | 2006 | — |
| −2 | K061732 | TAP-T | Airway Management, Inc. | 2006 | — |
| −1 | K103076 | Dynaflex | Dyna Flex | 2011 | — |
| 0 (this device) | K111009 | Acrylic Herbst Appliance | Embassy Dental Laboratory | 2011 | — |
| +1 | K113126 | Acrylic Herbst Appliance | Gergens Orthodontic Lab | 2013 | — |
| +2 | K170578 | True Function Adjustable Herbst Appliances | True Function Laboratory, Inc. | 2017 | — |
| +2 | K143591 | Dorsal Appliance | Gergens Orthodontic Lab | 2015 | — |
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 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K070327 | Removable Arylic Herbst, Allesee Snore Appliance (Asa), and Enoch SnorinatorSummary page 1…and mild to moderate obstructive sleep apnea (GSA) in adults 18 years of age or older. Predicate Devices: Allesee Orthodontic Appliances, Inc. (K070327) Specialty Appliances Works, Inc. (K083209) Dynaflex Inc. (K1 03076) Technological… | 2007 |
| * | K083209 | Acrylic Herbst Splint ApplianceSummary page 1…adults 18 years of age or older. Predicate Devices: Allesee Orthodontic Appliances, Inc. (K070327) Specialty Appliances Works, Inc. (K083209) Dynaflex Inc. (K1 03076) Technological The Acrylic Herbst Appliance possesses the same technologic… | 2009 |
| * | K103076 | DynaflexSummary page 1…redicate Devices: Allesee Orthodontic Appliances, Inc. (K070327) Specialty Appliances Works, Inc. (K083209) Dynaflex Inc. (K1 03076) Technological The Acrylic Herbst Appliance possesses the same technological Characteristics: characteristics as one… | 2011 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113126 | Acrylic Herbst Appliance | 2013 | 2 |
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 22 years and passes through 8 companies; a new generation was cleared every 2.7 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K113126 (Gergens Orthodontic Lab, 2013) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K070327.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Acrylic Herbst Appliance is intended for the reduction of night time 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/K111009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111009: Acrylic Herbst Appliance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111009
Report an extraction error
Are you the manufacturer?
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