Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LRK — Predicate Candidate Screening
214 FDA 510(k) clearances under this product code; the 50 most recent screened below.
142 daysmedian FDA review time
327 days90th percentile
214clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261912 | SnØreNegatØr | DnB Innovations, LLC | 2026-07-31 | 53 | 0 |
| K261366 | Virtus | Somnomed, Inc. | 2026-06-12 | 46 | 0 |
| K261251 | Snorbliss® Anti-Snoring Device | Endeavor Commerce, LLC | 2026-06-11 | 56 | 0 |
| K261134 | Dormiva Anti-Snoring Mouth Guard | Koncept Innovators, Inc. | 2026-05-14 | 37 | 0 |
| K252942 | ShaeferH | Shaeferh, LLC | 2026-04-10 | 207 | 0 |
| K253845 | Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08 | Ram.Shaw Pte. , Ltd. | 2026-03-03 | 91 | 0 |
| K252531 | Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1 | Myofunctional Research Co. | 2026-03-02 | 202 | 0 |
| K252976 | Park Dental Nylon MAD | Park Dental Research Corp. | 2025-12-18 | 92 | 0 |
| K253868 | QuietLab Pro | QuietLab, LLC | 2025-12-05 | 2 | 0 |
| K252161 | Hushd Avera | Good Sleep CO Pte , Ltd. | 2025-11-25 | 138 | 0 |
| K252525 | AIO Breathe | Aiomega, LLC | 2025-11-06 | 87 | 0 |
| K252698 | NightGuard Aire Max | Nightguard Express, LLC | 2025-11-03 | 68 | 0 |
| K253355 | Difiney Advanced Anti Snoring Device 4.0 | Fissiontech, LLC | 2025-10-29 | 29 | 0 |
| K251784 | Hushd Pro Z-Link | Good Sleep CO Pte , Ltd. | 2025-10-24 | 135 | 0 |
| K251628 | Mandibular Advancement Device L07 | Dcstar, Inc. | 2025-10-22 | 147 | 0 |
| K250028 | Anti Snore Mouthpiece | Dongguan Yiyao Science & Technology Development Co., Ltd. | 2025-10-03 | 270 | 0 |
| K243752 | Double Tube Herbst Appliance | The Tmj Clinic PC | 2025-09-17 | 286 | 0 |
| K252374 | Nylon flexTAP(R) | Airway Technologies D/B/A Airway Management | 2025-09-11 | 43 | 0 |
| K250353 | Oniris; Oniris Plus | Oniris | 2025-09-04 | 209 | 0 |
| K250122 | SleepRight Snore Aid | Splintek, Inc. | 2025-05-19 | 122 | 0 |
| K250482 | Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snorin | Fissiontech, LLC | 2025-05-08 | 78 | 0 |
| K234089 | DNA Appliance | Vivos Therapeutics | 2024-09-16 | 269 | 0 |
| K232025 | Hushd Pro Avera | Good Sleep CO Pte , Ltd. | 2024-05-09 | 307 | 0 |
| K232735 | EMA 3D | Ema Sleep Incorporated | 2024-05-03 | 239 | 0 |
| K233850 | Difiney Anti Snoring Device | Fissiontech, LLC | 2024-04-18 | 135 | 0 |
| K240427 | airVata™ | Gelb Practice Solutions, Inc. | 2024-02-14 | 1 | 0 |
| K231138 | Aniti-Snore Mouthguard+ | Oscimed SA | 2024-01-16 | 270 | 0 |
| K230947 | C.A.R.E. Appliance (DNA, mRNA, mmRNA) | Vivos Therapeutics, Inc. | 2023-11-28 | 238 | 0 |
| K233434 | Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGL | Prismatik Dentalcraft, Inc. | 2023-11-14 | 32 | 0 |
| K231663 | The AVEOtsd (Tongue Stabilizing Device) Mouthpiece | Innovative Health Technologies (Nz), Ltd. | 2023-09-18 | 103 | 0 |
| K223901 | ApneaRX Pro | Apnea Sciences Coporation | 2023-09-01 | 247 | 0 |
| K223624 | Emerald Herbst | Island Dental Lab, Inc Dba Emerald Dental | 2023-05-10 | 156 | 0 |
| K222872 | DNA Appliance | Vivos Therapeutics, Inc. | 2022-12-30 | 99 | 0 |
| K220688 | SilentZPro 2.0 | Shinrin-Yoku Traders, LLC | 2022-12-02 | 269 | 0 |
| K222475 | SNOR LOCK | Solbaro Co., Ltd. | 2022-11-10 | 86 | 0 |
| K221322 | CUSTMBITE Snoring System | Dental Choice Holdings, LLC | 2022-10-27 | 174 | 0 |
| K222127 | Soft Palate Elevator | The Tmj Clinic PC | 2022-10-24 | 98 | 0 |
| K221889 | ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH | Prosomnus Sleep Technologies | 2022-10-06 | 99 | 0 |
| K220330 | Soundly Anti Snoring Device | Greystone Ip, Ltd. | 2022-09-08 | 216 | 0 |
| K213088 | ZQuiet Advance | Sleeping Well, LLC | 2022-06-15 | 264 | 0 |
| K214096 | Respire Clear | Respire Medical, LLC | 2022-05-31 | 154 | 0 |
| K210636 | Morpheus | S4S UK , Ltd. | 2022-02-15 | 361 | 0 |
| K213475 | Elevo Snoring Intervention Set | Zelegent, Inc. | 2022-01-27 | 90 | 0 |
| K211069 | EndSnorZ Sleep Appliance | Prismatik Dentalcraft, Inc. | 2021-10-26 | 197 | 0 |
| K200657 | SmartGuard Anti-Snoring Device | Smartguard Rx, Inc. | 2021-08-23 | 529 | 0 |
| K210203 | mmRNA appliance | Vivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I) | 2021-08-19 | 205 | 0 |
| K210910 | Snore Bandit | Snorebandit, LLC | 2021-07-01 | 94 | 0 |
| K210694 | Silent Nite Sleep Appliance with the Glidewell Hinge | Prismatik Dentalcraft, Inc. | 2021-06-16 | 100 | 0 |
| K203606 | Serena Sleep Block Mandibular Advancement (BMA), Serena Slee | Meris Investment Group | 2021-03-10 | 90 | 0 |
| K203477 | Classic | Orthoapnea S.L. | 2021-02-25 | 90 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda