FDA product code · Dental
LRKDevice, Anti-Snoring
Product code LRK covers Device, Anti-Snoring, a Class II device regulated under 21 CFR 872.5570. FDA has cleared 213 devices in this code, 18 of them in the last 12 months. Median review time across the 213 most recent decisions is 142 days. openFDA lists 10 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 872.5570
- Review panel
- Dental
- Clearances
- 213
What is happening in LRK right now?
LRK (Device, Anti-Snoring) has four findings, most consequential first. 2 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2769-2026, Z-0956-2026). 12 first-time filers in the last 12 months, including Endeavor Commerce, LLC and Shaeferh, LLC (K261251, K252942, K253845, K252531, K252976). Clearances are running 36% faster — a median 91 days over the last 12 months against 142 days all-time (elapsed calendar days, not FDA review days) (LRK:review_time:12m). The code is crowded, scoring 97 of 100 — 147 companies hold a clearance here and 18 arrived in the last 12 months (LRK:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2769-2026, Z-0956-2026 |
| New entrant | Worth knowing | K261251, K252942, K253845, K252531, K252976 |
| Review time | Context | LRK:review_time:12m |
| Crowding | Context | LRK:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in LRK?
FDA has cleared 213 devices under product code LRK since the 510(k) programme began in 1976, 18 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261366 | Virtus | Somnomed, Inc. | |
| K261251 | Snorbliss® Anti-Snoring Device | Endeavor Commerce, LLC | |
| K261134 | Dormiva Anti-Snoring Mouth Guard | Koncept Innovators, Inc. | |
| K252942 | ShaeferH | Shaeferh, LLC | |
| K253845 | Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) | Ram.Shaw Pte. , Ltd. | |
| K252531 | Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) | Myofunctional Research Co. | |
| K252976 | Park Dental Nylon MAD | Park Dental Research Corp. | |
| K253868 | QuietLab Pro | QuietLab, LLC | |
| K252161 | Hushd Avera | Good Sleep CO Pte , Ltd. | |
| K252525 | AIO Breathe | Aiomega, LLC |
How long does FDA review take for LRK?
The median FDA review time for LRK is 142 days, measured across the 213 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in LRK?
openFDA lists 10 recall records against product code LRK. A recall record covers one firm's corrective action and may span many device lots.
Z-2769-2026Open, ClassifiedPrismatik Dentalcraft, Inc.
Due to device not having FDA Clearance
Z-0956-2026Open, ClassifiedMyofunctional Research Company USA
Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
Z-1494-2022Open, ClassifiedDental Choice Holding Llc
The device was marketed and sold in the US without FDA clearance.
Z-1947-2018TerminatedRespire Medical
Potential for device breakage during use
Z-1948-2018TerminatedRespire Medical
Potential for device breakage during use
Showing the 5 most recently initiated of 10. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for LRK?
MAUDE holds 1,153 adverse-event reports naming product code LRK, 643 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in LRK unusual?
2 months sit above LRK's own expected range: 1 July 2025, 1 December 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 8 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 18 | Insufficient history | No expected range — too little history | |
| 55 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 19 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 21 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 25 | 0–44 | Within expected (0–44) | |
| 22 | 0–39 | Within expected (0–39) | |
| 32 | 0–45 | Within expected (0–45) | |
| 34 | 1–49 | Within expected (1–49) | |
| 32 | 5–48 | Within expected (5–48) | |
| 38 | 9–49 | Within expected (9–49) | |
| 93 | 17–84 | Above expected (17–84) | |
| 52 | 16–78 | Within expected (16–78) | |
| 68 | 19–83 | Within expected (19–83) | |
| 84 | 21–90 | Within expected (21–90) | |
| 66 | 22–94 | Within expected (22–94) | |
| 110 | 27–107 | Above expected (27–107) | |
| 106 | 36–148 | Within expected (36–148) | |
| 90 | 34–129 | Within expected (34–129) | |
| 86 | 42–143 | Within expected (42–143) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in LRK.
Who has entered LRK in the last year?
8 companies filed in LRK for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Endeavor Commerce, LLC | K261251 | |
| Shaeferh, LLC | K252942 | |
| Ram.Shaw Pte. , Ltd. | K253845 | |
| Myofunctional Research Corp. Pty. , Ltd. | K252531 | |
| Park Dental Research Corporation | K252976 | |
| QuietLab, LLC | K253868 | |
| Aiomega, LLC | K252525 | |
| Nightguard Express, LLC | K252698 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in LRK?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in LRK?
Across the 213 most recent decisions, these applicants filed most often in LRK.
| Applicant | Recent clearances |
|---|---|
| Somnomed, Inc. | 8 |
| Sleeping Well, LLC | 6 |
| Airway Management, Inc. | 4 |
| Allen J. Moses, Dds, Ltd. | 4 |
| Oventus Manufacturing Pty, Ltd. | 4 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
2 companies in LRK file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Somnomed, Inc. | 9 | 2 |
| Always More Marketing, Inc. | 4 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch LRK
Get an email the morning anything changes in LRK — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
Related product codes in Dental
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.