510(k) · Cleared
ClearedDynaflex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dyna Flex · LRK Device, Anti-Snoring
Cleared on Feb 23, 2011 as substantially equivalent to K050592 (Somnomed, Ltd., 2005) and 2 other predicates after a 128-day review. Its family tree reaches back 7 generations to 1989. 29 later devices descend from it.
- Decided
- Feb 23, 2011
- Review
- 128 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K882303 (1989). 15 ancestors in all. 29 later devices descend from it, 6 citing it directly.
- 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 backK972061 TOAW. Keith Thornton, D.D.S. · 1997
- 4 generations backK022891 The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003
- 3 generations backK030440 Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc. · 2003
- 2 generations backK060388 Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with…Airway Management, Inc. · 2006
- 1 generation backK061732 TAP-TAirway Management, Inc. · 2006
- This deviceK103076 DynaflexDyna Flex · 2011
- Descendant · cites it directly · 17 of its ownK130130 Atg/SM-Osa AppliancesSelane Products, Inc. · 2013
- Descendant · cites it directly · 8 of its ownK160234 OVENTOventus Manufacturing Pty, Ltd. · 2016
- Descendant · 2 generations on · 7 of its ownK161832 O2VENT TOventus Manufacturing Pty, Ltd. · 2016
- Descendant · 2 generations on · 6 of its ownK192581 The NightBlocks ApplianceAdvanced Facialdontics, LLC · 2020
- Descendant · 2 generations on · 6 of its ownK171316 O2Vent WOventus Manufacturing Pty, Ltd. · 2017
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K130130Atg/SM-Osa AppliancesSelane Products, Inc. · 2013 · cites it directly17descendants
- K160234OVENTOventus Manufacturing Pty, Ltd. · 2016 · cites it directly8descendants
- K161832O2VENT TOventus Manufacturing Pty, Ltd. · 2016 · 2 generations on7descendants
- K192581The NightBlocks ApplianceAdvanced Facialdontics, LLC · 2020 · 2 generations on6descendants
- K171316O2Vent WOventus Manufacturing Pty, Ltd. · 2017 · 2 generations on6descendants
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 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| −4 | K022891 | The Breathe EZ Anti-Snoring Device | D&S Redhage | 2003 | — |
| −3 | K030440 | Oasys-Oral Airway System | Mark Abramson, D.D.S., Inc. | 2003 | — |
| −2 | K060388 | Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment | Airway Management, Inc. | 2006 | — |
| −1 | K061732 | TAP-T | Airway Management, Inc. | 2006 | — |
| 0 (this device) | K103076 | Dynaflex | Dyna Flex | 2011 | — |
| +1 | K130130 | Atg/SM-Osa Appliances | Selane Products, Inc. | 2013 | — |
| +1 | K160234 | OVENT | Oventus Manufacturing Pty, Ltd. | 2016 | — |
| +2 | K161832 | O2VENT T | Oventus Manufacturing Pty, Ltd. | 2016 | — |
| +2 | K192581 | The NightBlocks Appliance | Advanced Facialdontics, LLC | 2020 | — |
| +2 | K171316 | O2Vent W | Oventus Manufacturing Pty, Ltd. | 2017 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K050592 | Somnomed Mas RxaSummary page 3…2. Acrylic Splint Herbst Applance 3. TAP T 51 0(k)'s: I1. K050592 2. K083209 3. K061732 CDRH Product Classifi… | 2005 |
| * | K083209 | Acrylic Herbst Splint ApplianceSummary page 3…Herbst Applance 3. TAP T 51 0(k)'s: I1. K050592 2. K083209 3. K061732 CDRH Product Classification Name: Device, Anti-Snoring CDRH Produc… | 2009 |
| * | K061732 | TAP-TSummary page 3…3. TAP T 51 0(k)'s: I1. K050592 2. K083209 3. K061732 CDRH Product Classification Name: Device, Anti-Snoring CDRH Product Code: LRK CDRH Regulation Na… | 2006 |
What descends from it? (29)
See all 296 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 companies; a new generation was cleared every 2.7 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K130130 (Selane Products, Inc., 2013) has gone furthest, with 17 descendants of its own.
- 16 other devices also cite its predicate K050592.
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?
Dynalex® Anti-Snoring & Sleep Apnea Devices are intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults. The devices are worn while sleeping to support the lower jaw in a forward position prescribed by the dentist, and is removable by the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103076 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103076: Dynaflex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103076
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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