510(k) · Cleared
ClearedOasys-Oral Airway System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mark Abramson, D.D.S., Inc. · LRK Device, Anti-Snoring
Cleared on Aug 26, 2003 as substantially equivalent to K972061 (W. Keith Thornton, D.D.S., 1997) and 4 other predicates after a 196-day review. Its family tree reaches back 4 generations to 1989. 65 later devices descend from it.
- Decided
- Aug 26, 2003
- Review
- 196 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K882303 (1989). 8 ancestors in all. 65 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 3 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 2 generations backK972061 TOAW. Keith Thornton, D.D.S. · 1997
- 1 generation backK022891 The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003
- This deviceK030440 Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc. · 2003
- Descendant · cites it directly · 51 of its ownK060388 Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with…Airway Management, Inc. · 2006
- Descendant · 2 generations on · 32 of its ownK061732 TAP-TAirway Management, Inc. · 2006
- Descendant · 3 generations on · 29 of its ownK103076 DynaflexDyna Flex · 2011
- Descendant · 4 generations on · 17 of its ownK130130 Atg/SM-Osa AppliancesSelane Products, Inc. · 2013
- Descendant · 2 generations on · 15 of its ownK062951 Tap Iii Anti-Snoring DeviceAirway Management, Inc. · 2006
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 65 · See all- K060388Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with AttachmentAirway Management, Inc. · 2006 · cites it directly51descendants
- K061732TAP-TAirway Management, Inc. · 2006 · 2 generations on32descendants
- K103076DynaflexDyna Flex · 2011 · 3 generations on29descendants
- K130130Atg/SM-Osa AppliancesSelane Products, Inc. · 2013 · 4 generations on17descendants
- K062951Tap Iii Anti-Snoring DeviceAirway Management, Inc. · 2006 · 2 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −3 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −2 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| −1 | K022891 | The Breathe EZ Anti-Snoring Device | D&S Redhage | 2003 | — |
| 0 (this device) | K030440 | Oasys-Oral Airway System | Mark Abramson, D.D.S., Inc. | 2003 | — |
| +1 | 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 | — |
| +3 | K103076 | Dynaflex | Dyna Flex | 2011 | — |
| +4 | K130130 | Atg/SM-Osa Appliances | Selane Products, Inc. | 2013 | — |
| +2 | K062951 | Tap Iii Anti-Snoring Device | Airway Management, Inc. | 2006 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 5 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 6 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 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? (6)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K972061 | TOASummary page 1…Oral Appliance - anti-snoring device Device: OASYS -Oral Airway System Predicate Devices: Dr. Keith Thorton - K972061 Snore-Ezzer, LLC - K963063 Marketing Technologies,… | 1997 |
| * | K963063 | Snore TecSummary page 1…OASYS -Oral Airway System Predicate Devices: Dr. Keith Thorton - K972061 Snore-Ezzer, LLC - K963063 Marketing Technologies, Inc. - K9636 16 Nellcor Pur… | 1997 |
| Kept off the family tree | K963616 | FDA’s K963616 is Aloka SSD-1700 Diagnostic Ultrasound System Our reading of the summary gave K963616, FDA’s number for Aloka SSD-1700 Diagnostic Ultrasound System (Aloka Co., Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Marketing Technologies, Inc.”. Kept off the family tree. Summary page 1…Dr. Keith Thorton - K972061 Snore-Ezzer, LLC - K963063 Marketing Technologies, Inc. - K9636 16 Nellcor Puritan Bennett, Inc. - K9625 16 Device Description: The OASYS ORAL AIRWAY SYST… | 1997 |
| * | K962516 | Tap Anti-Snoring DeviceSummary page 1…zzer, LLC - K963063 Marketing Technologies, Inc. - K9636 16 Nellcor Puritan Bennett, Inc. - K9625 16 Device Description: The OASYS ORAL AIRWAY SYSTEM Anti-Snoring Device is composed of 0 Lower tray fitted over the lower t… | 1996 |
| * | K022891 | The Breathe EZ Anti-Snoring Device Cleared while this submission was under review | 2003 |
| * | K991948 | DR. B'S Mouthpiece, Model 32129-10002Summary page 2…o Predicate Devices: Attribute OASYS Breathe EZ Dr. ‘s Mouthpiece Marketing T.I. KO30440 KO2289 1 K99 1948 k963063 Intended as an Yes Yes Yes Yes intraoral device Intended to r… | 1999 |
What descends from it? (65)
See all 656 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060388 | Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment | 2006 | 51 |
| K111207 | Respire Blue Series | 2011 | 11 |
| K071560 | Provent Nasal Dilator, Model BR2 | 2008 | 10 |
| K111549 | Attune Sleep Apnea System | 2012 | 5 |
| K060744 | O'brien Mpa (Mandibular Positioning Applicance) | 2006 | 0 |
| K051014 | Silent Partner Series Osa Appliances | 2005 | 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 14 years and passes through 5 companies; a new generation was cleared every 5.5 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K060388 (Airway Management, Inc., 2006) has gone furthest, with 51 descendants of its own.
- 9 other devices also cite its predicate K972061.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
OASY.S Oral Airway System is intended for use to reduce or eleviate snoring and obstructive sleep apnea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030440 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030440: Oasys-Oral Airway System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030440
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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