510(k) · Cleared
ClearedC.A.R.E. Appliance (DNA, mRNA, mmRNA)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vivos Therapeutics, Inc. · LRK Device, Anti-Snoring
Cleared on Nov 28, 2023 as substantially equivalent to K222872 (Vivos Therapeutics, Inc., 2022) after a 238-day review. Its family tree reaches back 11 generations to 1989. 1 later device descends from it.
- Decided
- Nov 28, 2023
- Review
- 238 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K882303 (1989). 19 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 7 generations between
- 3 generations backK130130 Atg/SM-Osa AppliancesSelane Products, Inc. · 2013
- 2 generations backK130067 Mrna ApplianceBiomodeling Solutions, Lls · 2014
- 1 generation backK222872 DNA ApplianceVivos Therapeutics, Inc. · 2022
- This deviceK230947 C.A.R.E. Appliance (DNA, mRNA, mmRNA)Vivos Therapeutics, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK234089 DNA ApplianceVivos Therapeutics · 2024
Show all 11 generations
- Root · 11 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 10 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 9 generations backK972061 TOAW. Keith Thornton, D.D.S. · 1997
- 8 generations backK022891 The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003
- 7 generations backK030440 Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc. · 2003
- 6 generations backK060388 Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with…Airway Management, Inc. · 2006
- 5 generations backK061732 TAP-TAirway Management, Inc. · 2006
- 4 generations backK103076 DynaflexDyna Flex · 2011
- 3 generations backK130130 Atg/SM-Osa AppliancesSelane Products, Inc. · 2013
- 2 generations backK130067 Mrna ApplianceBiomodeling Solutions, Lls · 2014
- 1 generation backK222872 DNA ApplianceVivos Therapeutics, Inc. · 2022
- This deviceK230947 C.A.R.E. Appliance (DNA, mRNA, mmRNA)Vivos Therapeutics, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K234089DNA ApplianceVivos Therapeutics · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −10 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −9 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| −8 | K022891 | The Breathe EZ Anti-Snoring Device | D&S Redhage | 2003 | — |
| −7 | K030440 | Oasys-Oral Airway System | Mark Abramson, D.D.S., Inc. | 2003 | — |
| −6 | K060388 | Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment | Airway Management, Inc. | 2006 | — |
| −5 | K061732 | TAP-T | Airway Management, Inc. | 2006 | — |
| −4 | K103076 | Dynaflex | Dyna Flex | 2011 | — |
| −3 | K130130 | Atg/SM-Osa Appliances | Selane Products, Inc. | 2013 | — |
| −2 | K130067 | Mrna Appliance | Biomodeling Solutions, Lls | 2014 | — |
| −1 | K222872 | DNA Appliance | Vivos Therapeutics, Inc. | 2022 | — |
| 0 (this device) | K230947 | C.A.R.E. Appliance (DNA, mRNA, mmRNA) | Vivos Therapeutics, Inc. | 2023 | — |
| +1 | K234089 | DNA Appliance | Vivos Therapeutics | 2024 | — |
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 |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K222872 | DNA ApplianceSummary page 5…Sleep Apnea Device Classification Name Anti Snoring/ Obstructive Sleep Apnea Device Product Code LRK, LQZ Primary Predicate DNA (K222872) Reference Device mRNA (K130067) Reference Devices mmRNA (K210203) Device Description The C.A.R.E.… | 2022 |
| † | K130067 | Mrna Appliance | 2014 |
| † | K210203 | mmRNA appliance | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K234089 | DNA Appliance | 2024 | 0 |
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 10 companies; a new generation was cleared every 2.5 years on median.
- None of the 19 ancestors has a recall.
- Of its descendants, K234089 (Vivos Therapeutics, 2024) has gone furthest, with 0 descendants of its own.
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 C.A.R.E. Appliances are intended to reduce nighttime snoring and to treat mild and moderate obstructive sleep apnea in adults, 18 years of age and older. The C.A.R.E. Appliances are also intended to treat moderate and severe obstructive sleep apnea (OSA) in adults, 18 years of age and older along with positive airway pressure (PAP) devices and/or myofunctional therapy, as needed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230947 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230947: C.A.R.E. Appliance (DNA, mRNA, mmRNA).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230947
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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