321Q Minimum Energy Tinnitus Suppressor

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K922572 ↗

FDA Product Code

KLW

Device Class

Class II

Regulation

21 CFR Part 874.3400

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Microtek's Surgical Lamp Handle & Cover

  Class II

  FDA 510(k) K901154 Active Cleared 20 Mar 1990

• Microtek Medical's Sound Stiks

  Class II

  FDA 510(k) K913276 Active Cleared 21 Oct 1991

• Disposable Arachnoid Knife

  Class I

  FDA 510(k) K882422 Active Cleared 6 Sep 1988

• Microtek Reuter-Style Bi-Valve Intranasal Splint

  Class I

  FDA 510(k) K895502 Active Cleared 8 Dec 1989

• Microtek-Heritages Silicone Bulb Evacuation System

  Class I

  FDA 510(k) K910167 Active Cleared 15 Apr 1991

• Ossicular Prostheses 4 Partial, 4 Total, 2 Convert

  Class II

  FDA 510(k) K885201 Active Cleared 19 Apr 1989

See all devices from Microbio-Medics, Inc. →

• What is the 321Q Tinnitus Suppressor used for?

  It is a non-invasive tinnitus management tool designed to alleviate the perception of tinnitus by delivering low-level acoustic energy. The device uses targeted sound frequencies to reduce the contrast between internal tinnitus and the external environment, providing relief without excessive volume or discomfort. It is intended for use in clinical or home settings.

• How is the 321Q device supplied and is it sterile?

  The available regulatory data does not specify the exact supply format, sterility status, or packaging details for the 321Q Minimum Energy Tinnitus Suppressor. Specifications indicate it is a single-use or limited-use system depending on the specific configuration, but further details on sterility are not provided in the records.

• What is the regulatory status and classification of this device?

  The 321Q Minimum Energy Tinnitus Suppressor is classified as a Class II medical device under product code KLW as a tinnitus masker. It was authorized through the FDA 510(k) premarket notification pathway under reference number K922572, with a substantial equivalence decision dated November 2, 1992. It falls under the regulatory specialty of Ear, Nose, and Throat.

• Are there any specific storage or MRI safety details available?

  The available regulatory data for the 321Q Minimum Energy Tinnitus Suppressor does not include specific storage conditions or MRI safety profiles. Users should refer to the manufacturer's labeling or contact Microbio-Medics, Inc. directly for detailed handling and safety instructions.