510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K242304Substantially Equivalent

Red

Neuraxis, Inc, Carmel IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K242304 is the FDA 510(k) clearance record for RED, a class II device, cleared for Neuraxis, Inc. on under FDA product code KLA (Monitor, Esophageal Motility, Anorectal Motility, And Tube). FDA records list 4 510(k) clearances for Neuraxis, Inc., from to . As of , FDA records show no recalls naming K242304.

Clearance record

Decision date
Received
(123 days to decision)
Product code
KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube
Regulation
21 CFR 876.1725
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Neuraxis, Inc. 11611 N. Meridian St., Carmel IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KLA

Trailing 12 months

FDA records hold no clearances under product code KLA in the trailing twelve months.

FDA records show no clearances under product code KLA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KLA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260