510(k) · Cleared
ClearedTap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Airway Management, Inc. · LRK Device, Anti-Snoring
Cleared on May 17, 2006 as substantially equivalent to K962516 (Nellcor Puritan Bennett, Inc., 1996) and 2 other predicates after a 92-day review. Its family tree reaches back 5 generations to 1989. 51 later devices descend from it.
- Decided
- May 17, 2006
- Review
- 92 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K882303 (1989). 9 ancestors in all. 51 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 4 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 3 generations backK972061 TOAW. Keith Thornton, D.D.S. · 1997
- 2 generations backK022891 The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003
- 1 generation backK030440 Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc. · 2003
- This deviceK060388 Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with…Airway Management, Inc. · 2006
- Descendant · cites it directly · 32 of its ownK061732 TAP-TAirway Management, Inc. · 2006
- Descendant · 2 generations on · 29 of its ownK103076 DynaflexDyna Flex · 2011
- Descendant · 3 generations on · 17 of its ownK130130 Atg/SM-Osa AppliancesSelane Products, Inc. · 2013
- Descendant · cites it directly · 15 of its ownK062951 Tap Iii Anti-Snoring DeviceAirway Management, Inc. · 2006
- Descendant · cites it directly · 11 of its ownK111207 Respire Blue SeriesRespire Medical · 2011
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 51 · See all- K061732TAP-TAirway Management, Inc. · 2006 · cites it directly32descendants
- K103076DynaflexDyna Flex · 2011 · 2 generations on29descendants
- K130130Atg/SM-Osa AppliancesSelane Products, Inc. · 2013 · 3 generations on17descendants
- K062951Tap Iii Anti-Snoring DeviceAirway Management, Inc. · 2006 · cites it directly15descendants
- K111207Respire Blue SeriesRespire Medical · 2011 · cites it directly11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −4 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −3 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| −2 | K022891 | The Breathe EZ Anti-Snoring Device | D&S Redhage | 2003 | — |
| −1 | K030440 | Oasys-Oral Airway System | Mark Abramson, D.D.S., Inc. | 2003 | — |
| 0 (this device) | 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 | — |
| +2 | K103076 | Dynaflex | Dyna Flex | 2011 | — |
| +3 | K130130 | Atg/SM-Osa Appliances | Selane Products, Inc. | 2013 | — |
| +1 | K062951 | Tap Iii Anti-Snoring Device | Airway Management, Inc. | 2006 | — |
| +1 | K111207 | Respire Blue Series | Respire Medical | 2011 | — |
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 |
|---|---|---|
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 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? (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 |
|---|---|---|---|
| * | K962516 | Tap Anti-Snoring DeviceSummary page 1…anti snoring device. Classification Name Anti -Snoring device Device: TAP II Predicate Device Nelicor Puritan Bennett - TAP-K962516 Thornton Oral Appliance - TOA-K972061 OASYS Oral Airway System - K030… | 1996 |
| * | K972061 | TOASummary page 1…vice Device: TAP II Predicate Device Nelicor Puritan Bennett - TAP-K962516 Thornton Oral Appliance - TOA-K972061 OASYS Oral Airway System - K030440 The TAP II Anti-Snoring device is comprised of:… | 1997 |
| * | K030440 | Oasys-Oral Airway SystemSummary page 1…Nelicor Puritan Bennett - TAP-K962516 Thornton Oral Appliance - TOA-K972061 OASYS Oral Airway System - K030440 The TAP II Anti-Snoring device is comprised of: *Lower tray fitted over the lower teeth. *Upper tra… | 2003 |
What descends from it? (51)
See all 514 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 17 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K061732 (Airway Management, Inc., 2006) has gone furthest, with 32 descendants of its own.
- 12 other devices also cite its predicate K962516.
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?
To reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea (OSA).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060388 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060388: Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060388
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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