Circumaural Adhesive Replacement
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K111555 FDA 510(k)
- FDA Product Code
- GWJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1900 FDA 510(k)
- Regulation Number
- 882.1900 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is a Circumaural Adhesive Replacement, classified as a Stimulator, Auditory, Evoked Response under FDA device class 2. It consists of acrylic hydrogel adhesive rings supplied on a release card in packages of ten, designed to replace the original adhesive on disposable ear couplers.
It is used by removing the top liner covers and applying the adhesive rings to earphones after the original adhesive is removed from the disposable ear couplers. The device is supplied non-sterile, intended for single-use, and has no stated MRI safety information. Storage conditions and specific sizes are not detailed in the provided data. Authorization is based on FDA 510(k) clearance K111555, granted as substantially equivalent to a predicate device.
Frequently asked questions
What is the Circumaural Adhesive Replacement used for?
The device is used to replace the original adhesive on disposable ear couplers by removing the top liner covers and applying the acrylic hydrogel adhesive rings to earphones, enabling secure attachment for auditory evoked response stimulation.
How is the Circumaural Adhesive Replacement supplied and packaged?
The device consists of acrylic hydrogel adhesive rings supplied on a release card in packages of ten, provided non-sterile and intended for single-use application after removal of the original adhesive from disposable ear couplers.
Is the Circumaural Adhesive Replacement sterile or reusable?
The device is supplied non-sterile and is intended for single-use only; it is not designed for reuse, reprocessing, or resterilization after initial application to ear couplers.
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: K111555 FDA 510 (k) - CIRCUMAURAL ADHESIVE REPLACEMENT, CIRCUMAURAL ADHESIVE REPLACEMENT (K111555) — FDA 510 (k) | Innolitics, PDF K111555 - Circumaural Adhesive Replacement, PDF 5. 510(k) Summary juL 2 5 2011 - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K111555 | Class II | Active |
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Manufacturer
- Manufacturer
- R & D Medical Products, Inc.
Sources (1)
- FDA 510(k) K111555 24 fields · synced Oct 6, 2026