# K242304: RED

- Pathway: 510(k) (Traditional)
- Applicant: Neuraxis, Inc.
- Decided: Dec 6, 2024 after 123 days
- Product code: KLA (Monitor, Esophageal Motility, Anorectal Motility, And Tube)
- Device class: 2
- Regulation: 21 CFR 876.1725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K931574 (1993). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180135: THD Anopress with THD SensyProbe, Thd Spa (2018) Summary page 5.
- K823701: Motility Catheters, Mui Scientific (1983) Summary page 5.

## Indications for use
RED is used to evaluate the neuromuscular function of the patient’s ability to expel its contents from the rectum and as a qualitative test for rectal hypersensitivity. RED helps identify patients with rectal hypersensitivity who experience desire or urge-to-defecate at lower volumes of distension. RED is intended to be used in a clinical setting by trained health care providers in adult populations.

Source page: https://510kreport.com/device/K242304
Methodology: https://510kreport.com/methodology