510(k) · Cleared
ClearedThe Breathe EZ Anti-Snoring Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
D&S Redhage · LRK Device, Anti-Snoring
Cleared on Feb 19, 2003 as substantially equivalent to K991948 (Snore - Ezzer, 1999) and 3 other predicates after a 173-day review. Its family tree reaches back 3 generations to 1989. 75 later devices descend from it.
- Decided
- Feb 19, 2003
- Review
- 173 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K882303 (1989). 7 ancestors in all. 75 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 2 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 1 generation backK972061 TOAW. Keith Thornton, D.D.S. · 1997
- This deviceK022891 The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003
- Descendant · cites it directly · 65 of its ownK030440 Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc. · 2003
- Descendant · 2 generations on · 51 of its ownK060388 Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with…Airway Management, Inc. · 2006
- Descendant · 3 generations on · 32 of its ownK061732 TAP-TAirway Management, Inc. · 2006
- Descendant · 4 generations on · 29 of its ownK103076 DynaflexDyna Flex · 2011
- Descendant · 5 generations on · 17 of its ownK130130 Atg/SM-Osa AppliancesSelane Products, Inc. · 2013
Showing 5 of 75 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 75 · See all- K030440Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc. · 2003 · cites it directly65descendants
- K060388Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with AttachmentAirway Management, Inc. · 2006 · 2 generations on51descendants
- K061732TAP-TAirway Management, Inc. · 2006 · 3 generations on32descendants
- K103076DynaflexDyna Flex · 2011 · 4 generations on29descendants
- K130130Atg/SM-Osa AppliancesSelane Products, Inc. · 2013 · 5 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −2 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −1 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| 0 (this device) | K022891 | The Breathe EZ Anti-Snoring Device | D&S Redhage | 2003 | — |
| +1 | 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 | — |
| +3 | K061732 | TAP-T | Airway Management, Inc. | 2006 | — |
| +4 | K103076 | Dynaflex | Dyna Flex | 2011 | — |
| +5 | K130130 | Atg/SM-Osa Appliances | Selane Products, Inc. | 2013 | — |
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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 6 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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? (4)
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 |
|---|---|---|---|
| * | K991948 | DR. B'S Mouthpiece, Model 32129-10002Summary page 1…l Appliance: anti-snoringlgrinding Device Classification Name: Anti-snoring device Predicated Devices: Snore-Ezzer, LLC - K99 1948 Marketing Technologies, Inc. - K963063… | 1999 |
| * | K963063 | Snore TecSummary page 1…snoring device Predicated Devices: Snore-Ezzer, LLC - K99 1948 Marketing Technologies, Inc. - K963063 Nellcor Puritan Bennett Inc. - K962516… | 1997 |
| * | K962516 | Tap Anti-Snoring DeviceSummary page 1…948 Marketing Technologies, Inc. - K963063 Nellcor Puritan Bennett Inc. - K962516 Dr. Kieth Thornton - IC972061 Device Description: The Breathe E 2 Anti-SnorindA… | 1996 |
| * | K972061 | TOASummary page 2…The Breathe EZ Dr. B’s Mouthpiece Marketing T. I Nellcor P.B. K991948 K963063 K972061 - Use: Intended as an Yes Yes Yes Yes intraoral device Intended to… | 1997 |
What descends from it? (75)
See all 753 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 14 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K030440 (Mark Abramson, D.D.S., Inc., 2003) has gone furthest, with 65 descendants of its own.
- 3 other devices also cite its predicate K991948.
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?
The Breath EZ Anti-Snoring Device is intended to reduce or alleviate snoring by maintaining an open airway and to prevent bruxing, clenching and grinding of the teeth while sleeping.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022891 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022891: The Breathe EZ Anti-Snoring Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022891
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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