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Snore Guard

FDA 510(k)

Class II (US FDA 510(k))

510(k) K103004

by Ranir, Llc

Identifiers

510(k) Number
K103004 FDA 510(k)
FDA Product Code
LRK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.5570 FDA 510(k)
Regulation Number
872.5570 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Snore Guard is a dental anti-snoring device. It is classified as a Class II medical device under FDA regulation number 872.5570.

The device received FDA 510(k) clearance (K103004) on February 25, 2011, and is substantially equivalent to a legally marketed device. It is manufactured by Ranir, LLC and assigned product code LRK.

Frequently asked questions

What is the Snore Guard used for?

The Snore Guard is a dental anti-snoring device designed to reduce snoring by repositioning the jaw during sleep. It is intended for patients who experience snoring due to mild to moderate obstructive airway issues, as indicated by its classification under FDA regulation 872.5570 for anti-snoring devices.

Is the Snore Guard a single-use or reusable device?

The Snore Guard is a reusable dental device intended for multiple uses over time. It is made from durable materials suitable for repeated insertion and removal in the mouth, and users are instructed to clean it regularly according to the manufacturer’s guidelines to maintain hygiene and effectiveness.

How is the Snore Guard supplied and what are its regulatory details?

The Snore Guard is supplied as a finished dental device by Ranir, LLC. It received FDA 510(k) clearance under K103004 on February 25, 2011, and is classified as a Class II medical device with product code LRK and regulation number 872.5570. It was determined to be substantially equivalent to a predicate device already on the market.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MAUDE Adverse Event Report: RANIR LLC SNOREGUARD; DEVICE, ANTI-SNORING, SNOREGUARD SNORE GUARD Adverse Event MAUDE, 510(k) Premarket Notification - Food and Drug Administration, Snore Guard Advance 510 (k) FDA Premarket Notification K102118 RANIR LLC, SNORE GUARD (K103004) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ranir, Llc

Sources (1)

  • FDA 510(k) K103004 24 fields · synced Sep 22, 2026