Identifiers
- 510(k) Number
- K242304 FDA 510(k)
- FDA Product Code
- KLA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1725 FDA 510(k)
- Regulation Number
- 876.1725 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The RED is a rectal expulsion device designed to self-inflate to a set volume with a special foam that mimics the feel of stool in the rectum. It is intended to assess pelvic floor dysfunction and rectal hypersensitivity in patients with chronic constipation by duplicating the test performance of traditional balloon expulsion test and manual sensation testing devices.
The RED is supplied as a point-of-care tool that requires no electronics or software. It is authorized under FDA 510(k) clearance (K242304) and classified as a Class II device under regulation number 876.1725 with product code KLA. The device is manufactured by Neuraxis, Inc. in Carmel, Indiana.
Frequently asked questions
What is the RED device used for?
The RED device is used to assess pelvic floor dysfunction and rectal hypersensitivity in patients with chronic constipation by duplicating the test performance of traditional balloon expulsion test and manual sensation testing devices.
How is the RED device supplied?
The RED is supplied as a point-of-care tool that requires no electronics or software.
Is the RED device authorized by the FDA?
Yes, the RED device is authorized under FDA 510(k) clearance (K242304) and classified as a Class II device under regulation number 876.1725.
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: RED - Rectal Expulsion Device - NeurAxis, NeurAxis - Neuromodulation therapies for chronic and debilitating ..., NeurAxis Inc. Announces FDA 510 (k) Clearance of RED for Testing and ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242304 | Class II | Active |
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Manufacturer
- Manufacturer
- Neuraxis, Inc.
Sources (1)
- FDA 510(k) K242304 24 fields · synced Sep 21, 2026