510(k) · Cleared
ClearedNarval CC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resmed Sas · LQZ Device, Jaw Repositioning
Cleared on Dec 1, 2011 as substantially equivalent to K050592 (Somnomed, Ltd., 2005) and 1 other predicate after a 31-day review. Its family tree reaches back 4 generations to 1989. 15 later devices descend from it.
- Decided
- Dec 1, 2011
- Review
- 31 days
- Class
- Class II
- Product code
- LQZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K882303 (1989). 8 ancestors in all, the oldest K880956 (1988). 15 later devices descend from it, 3 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 backK042161 Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd. · 2004
- 1 generation backK050592 Somnomed Mas RxaSomnomed, Ltd. · 2005
- This deviceK113201 Narval CCResmed Sas · 2011
- Descendant · cites it directly · 9 of its ownK143244 The Panthera Anti-Snoring DevicePanthera Dental, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK153291 Sicat OptisleepSicat GmbH & Co. KG · 2016
- Descendant · 2 generations on · 2 of its ownK203596 Panthera Occlusal AppliancePanthera Dental, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK232025 Hushd Pro AveraGood Sleep CO Pte, Ltd. · 2024
- Descendant · 3 generations on · 1 of its ownK230495 Serena Sleep Night GuardMeris Investment Group · 2023
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K143244The Panthera Anti-Snoring DevicePanthera Dental, Inc. · 2014 · cites it directly9descendants
- K153291Sicat OptisleepSicat GmbH & Co. KG · 2016 · cites it directly3descendants
- K203596Panthera Occlusal AppliancePanthera Dental, Inc. · 2021 · 2 generations on2descendants
- K232025Hushd Pro AveraGood Sleep CO Pte, Ltd. · 2024 · 2 generations on1descendant
- K230495Serena Sleep Night GuardMeris Investment Group · 2023 · 3 generations on1descendant
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 | K042161 | Anti-Snoring/Sleep Apnea Device | Rj & VK Bird Pty, Ltd. | 2004 | — |
| −1 | K050592 | Somnomed Mas Rxa | Somnomed, Ltd. | 2005 | — |
| 0 (this device) | K113201 | Narval CC | Resmed Sas | 2011 | — |
| +1 | K143244 | The Panthera Anti-Snoring Device | Panthera Dental, Inc. | 2014 | — |
| +1 | K153291 | Sicat Optisleep | Sicat GmbH & Co. KG | 2016 | — |
| +2 | K203596 | Panthera Occlusal Appliance | Panthera Dental, Inc. | 2021 | — |
| +2 | K232025 | Hushd Pro Avera | Good Sleep CO Pte, Ltd. | 2024 | — |
| +3 | K230495 | Serena Sleep Night Guard | Meris Investment Group | 2023 | — |
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 |
|---|---|---|
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 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 LQZ? 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 LQZ device
- #1 K233754 AIO Breathescore 12.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K050592 | Somnomed Mas RxaSummary page 1…lassification Name Classification 21 CFR 872.5570 (Class 11) Product LQZ Predicate Somnomed MAS RxA (K050592) Frantz Elastic Mandibular Advancement (EMA) Appliance (K971794) Description… | 2005 |
| * | K971794 | Elastic Mandibular Advancement (Ema) ApplianceSummary page 1…Product LQZ Predicate Somnomed MAS RxA (K050592) Frantz Elastic Mandibular Advancement (EMA) Appliance (K971794) Description The Narval CC is a removable intraoral device used for treating snoring and… | 1997 |
What descends from it? (15)
See all 153 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 22 years and passes through 5 companies; a new generation was cleared every 7.4 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K143244 (Panthera Dental, Inc., 2014) has gone furthest, with 9 descendants of its own.
- 16 other devices also cite its predicate K050592.
How does its category compare?
All LQZ devicesLQZ Device, Jaw Repositioning: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LQZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LQZ
Too few LQZ 510(k)s in any year since 2007 to give a median.
Recalls per year · LQZ
No recall names LQZ since 2007.
Adverse event reports per year · LQZ
2in 2021
MAUDE reports naming product code LQZ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Narval CC™ 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/K113201 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113201: Narval CC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113201
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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