510(k) · Cleared
ClearedThe Panthera Anti-Snoring Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Panthera Dental, Inc. · LRK Device, Anti-Snoring
Cleared on Dec 15, 2014 as substantially equivalent to K113201 (Resmed Sas, 2011) after a 33-day review. Its family tree reaches back 5 generations to 1989. 9 later devices descend from it.
- Decided
- Dec 15, 2014
- Review
- 33 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K882303 (1989). 9 ancestors in all, the oldest K880956 (1988). 9 later devices descend from it, 5 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 backK042161 Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd. · 2004
- 2 generations backK050592 Somnomed Mas RxaSomnomed, Ltd. · 2005
- 1 generation backK113201 Narval CCResmed Sas · 2011
- This deviceK143244 The Panthera Anti-Snoring DevicePanthera Dental, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK203596 Panthera Occlusal AppliancePanthera Dental, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK232025 Hushd Pro AveraGood Sleep CO Pte, Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK230495 Serena Sleep Night GuardMeris Investment Group · 2023
- Descendant · cites it directly · 1 of its ownK171576 The Panthera Anti-Snoring X3 DevicePanthera Dental, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK252976 Park Dental Nylon MADPark Dental Research Corp. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K203596Panthera Occlusal AppliancePanthera Dental, Inc. · 2021 · cites it directly2descendants
- K232025Hushd Pro AveraGood Sleep CO Pte, Ltd. · 2024 · cites it directly1descendant
- K230495Serena Sleep Night GuardMeris Investment Group · 2023 · 2 generations on1descendant
- K171576The Panthera Anti-Snoring X3 DevicePanthera Dental, Inc. · 2018 · cites it directly1descendant
- K252976Park Dental Nylon MADPark Dental Research Corp. · 2025 · 2 generations on0descendants
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 | K042161 | Anti-Snoring/Sleep Apnea Device | Rj & VK Bird Pty, Ltd. | 2004 | — |
| −2 | K050592 | Somnomed Mas Rxa | Somnomed, Ltd. | 2005 | — |
| −1 | K113201 | Narval CC | Resmed Sas | 2011 | — |
| 0 (this device) | K143244 | The Panthera Anti-Snoring Device | Panthera Dental, Inc. | 2014 | — |
| +1 | K203596 | Panthera Occlusal Appliance | Panthera Dental, Inc. | 2021 | — |
| +1 | K232025 | Hushd Pro Avera | Good Sleep CO Pte, Ltd. | 2024 | — |
| +2 | K230495 | Serena Sleep Night Guard | Meris Investment Group | 2023 | — |
| +1 | K171576 | The Panthera Anti-Snoring X3 Device | Panthera Dental, Inc. | 2018 | — |
| +2 | K252976 | Park Dental Nylon MAD | Park Dental Research Corp. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K113201 | Narval CCSummary page 5…Mandibular repositioning device Classification: 21 CFR 872.5570 (Class II) Product: LRK Predicate: Narval CC (K113201) Description: The Panthera Anti-Snoring Device is a removable intraoral device used for treating snoring and mild to moderate ob… | 2011 |
What descends from it? (9)
5 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 25 years and passes through 6 companies; a new generation was cleared every 6.4 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K203596 (Panthera Dental, Inc., 2021) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K113201.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
The Panthera Anti-Snoring Device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143244 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143244: The Panthera 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/K143244
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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