510(k) · Cleared
ClearedDorsal Appliance
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gergens Orthodontic Lab · LRK Device, Anti-Snoring
Cleared on Apr 15, 2015 as substantially equivalent to K113126 (Gergens Orthodontic Lab, 2013) after a 118-day review. Its family tree reaches back 10 generations to 1989.
- Decided
- Apr 15, 2015
- Review
- 118 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K882303 (1989). 18 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 backK103076 DynaflexDyna Flex · 2011
- 2 generations backK111009 Acrylic Herbst ApplianceEmbassy Dental Laboratory · 2011
- 1 generation backK113126 Acrylic Herbst ApplianceGergens Orthodontic Lab · 2013
- This deviceK143591 Dorsal ApplianceGergens Orthodontic Lab · 2015
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 backK972061 TOAW. Keith Thornton, D.D.S. · 1997
- 7 generations backK022891 The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003
- 6 generations backK030440 Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc. · 2003
- 5 generations backK060388 Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with…Airway Management, Inc. · 2006
- 4 generations backK061732 TAP-TAirway Management, Inc. · 2006
- 3 generations backK103076 DynaflexDyna Flex · 2011
- 2 generations backK111009 Acrylic Herbst ApplianceEmbassy Dental Laboratory · 2011
- 1 generation backK113126 Acrylic Herbst ApplianceGergens Orthodontic Lab · 2013
- This deviceK143591 Dorsal ApplianceGergens Orthodontic Lab · 2015
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 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| −7 | K022891 | The Breathe EZ Anti-Snoring Device | D&S Redhage | 2003 | — |
| −6 | K030440 | Oasys-Oral Airway System | Mark Abramson, D.D.S., Inc. | 2003 | — |
| −5 | K060388 | Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment | Airway Management, Inc. | 2006 | — |
| −4 | K061732 | TAP-T | Airway Management, Inc. | 2006 | — |
| −3 | K103076 | Dynaflex | Dyna Flex | 2011 | — |
| −2 | K111009 | Acrylic Herbst Appliance | Embassy Dental Laboratory | 2011 | — |
| −1 | K113126 | Acrylic Herbst Appliance | Gergens Orthodontic Lab | 2013 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K113126 | Acrylic Herbst ApplianceSummary page 4…hacrylate (acrylic splints) and stainless steel (adjustment screw mechanism) Predicate Devices: Primary: Acrylic Herbst Appliance (Gergen’s, K113126) Reference: Dorsal Appliance (Dynaflex Inc., K103076) Performance Data: The materials and fabricati… | 2013 |
| † | K103076 | Dynaflex | 2011 |
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 9 companies; a new generation was cleared every 2.0 years on median.
- None of the 18 ancestors has a recall.
- 1 other device also cites its predicate K113126.
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?
The Dorsal 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/K143591 · printed Nov 4, 2026
Cite this page
510(k) Report. “K143591: Dorsal Appliance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K143591
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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