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SnoreRx 9.0

by Consumer Health Products, Inc.

510(k) K112205

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK112205 Date16 Nov 2011ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LRK
Device Class
Class II
Regulation
21 CFR Part 872.5570
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SnoreRx 9.0 is a Class 2 dental device intended as an anti-snoring aid for adult patients 18 years of age or older. It is a substantially equivalent device cleared via the abbreviated 510(k) pathway under regulation number 872.5570 with product code LRK.

Manufactured by Consumer Health Products, Inc., the device received FDA 510(k) clearance (K112205) on November 16, 2011, following a 107-day review. It is supplied as a reusable dental device for use in reducing snoring in adult patients.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the SnoreRx 9.0 used for?

    The SnoreRx 9.0 is used as an anti-snoring aid for adult patients 18 years of age or older.

  • Is the SnoreRx 9.0 reusable?

    Yes, the SnoreRx 9.0 is supplied as a reusable dental device.

  • What regulatory pathway was used for clearance?

    The SnoreRx 9.0 was cleared via the abbreviated 510(k) pathway under regulation number 872.5570.