510(k) · Cleared
ClearedTap Anti-Snoring Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nellcor Puritan Bennett, Inc. · LRK Device, Anti-Snoring
Cleared on Sep 10, 1996 as substantially equivalent to K882303 (Hays & Meade, Inc., 1989) and 1 other predicate after a 75-day review. Its family tree reaches back 1 generation to 1989. 152 later devices descend from it.
- Decided
- Sep 10, 1996
- Review
- 75 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K882303 (1989). 2 ancestors in all. 152 later devices descend from it, 13 citing it directly.
- Root · 1 generation backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- This deviceK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- Descendant · cites it directly · 109 of its ownK042161 Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd. · 2004
- Descendant · cites it directly · 95 of its ownK972061 TOAW. Keith Thornton, D.D.S. · 1997
- Descendant · 2 generations on · 86 of its ownK050592 Somnomed Mas RxaSomnomed, Ltd. · 2005
- Descendant · cites it directly · 75 of its ownK022891 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
Showing 5 of 152 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 152 · See all- K042161Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd. · 2004 · cites it directly109descendants
- K972061TOAW. Keith Thornton, D.D.S. · 1997 · cites it directly95descendants
- K050592Somnomed Mas RxaSomnomed, Ltd. · 2005 · 2 generations on86descendants
- K022891The Breathe EZ Anti-Snoring DeviceD&S Redhage · 2003 · cites it directly75descendants
- K030440Oasys-Oral Airway SystemMark Abramson, D.D.S., Inc. · 2003 · cites it directly65descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| 0 (this device) | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| +1 | K042161 | Anti-Snoring/Sleep Apnea Device | Rj & VK Bird Pty, Ltd. | 2004 | — |
| +1 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| +2 | K050592 | Somnomed Mas Rxa | Somnomed, Ltd. | 2005 | — |
| +1 | K022891 | The Breathe EZ Anti-Snoring Device | D&S Redhage | 2003 | — |
| +1 | K030440 | Oasys-Oral Airway System | Mark Abramson, D.D.S., Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 7 | 0 |
| 2008 | 2 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 7 | 0 |
| 2012 | 10 | 0 |
| 2013 | 9 | 0 |
| 2014 | 11 | 0 |
| 2015 | 7 | 0 |
| 2016 | 9 | 0 |
| 2017 | 8 | 0 |
| 2018 | 5 | 0 |
| 2019 | 9 | 0 |
| 2020 | 8 | 0 |
| 2021 | 9 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 7 | 0 |
| 2025 | 9 | 0 |
| 2026 | 7 | 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 |
|---|---|---|---|
| * | K882303 | H&M Anti-Snoring DeviceSummary page 1…(612) 941-3006 Fax - (612) 829-5423 Chris Hadland, Director, RA and QA TAP Oral Appliance - anti-snoring device Anti-snoring device TAP H&M Anti-snoring device - K882303 Distar, Inc. - TheraSnore - K926382 Dental Services group - PM and Adjustable PM Positioner - K# unknown Device Description:… | 1989 |
| * | K926382 | TherasnoreSummary page 1…Chris Hadland, Director, RA and QA TAP Oral Appliance - anti-snoring device Anti-snoring device TAP H&M Anti-snoring device - K882303 Distar, Inc. - TheraSnore - K926382 Dental Services group - PM and Adjustable PM Positioner - K# unknown Device Description: The TAP anti-snoring device is compri… | 1993 |
| * | — | Dental Services group - PM and Adjustable PM Positioner Named without a submission number |
What descends from it? (152)
See all 15213 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042161 | Anti-Snoring/Sleep Apnea Device | 2004 | 109 |
| K972061 | TOA | 1997 | 95 |
| K022891 | The Breathe EZ Anti-Snoring Device | 2003 | 75 |
| K030440 | Oasys-Oral Airway System | 2003 | 65 |
| K060388 | Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment | 2006 | 51 |
| K061732 | TAP-T | 2006 | 32 |
| K061688 | Anti-Snoring / Sleep Apnea Device | 2006 | 22 |
| K062951 | Tap Iii Anti-Snoring Device | 2006 | 15 |
| K082723 | Grindguard | 2009 | 10 |
| K060795 | Somnofit | 2006 | 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?
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 TAP is intended to reduce or alleviate night time snoring.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962516 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962516: Tap Anti-Snoring Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962516
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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