510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K223031Substantially Equivalent

Vibrant System

Vibrant Ltd, Yokneam, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223031 is the FDA 510(k) clearance record for Vibrant System, a class II device, cleared for Vibrant, Ltd. on under FDA product code QTN (Orally Ingested Transient Device For Constipation). FDA's definition for product code QTN reads: "An orally ingested transient device for constipation is an electric swallowable capsule that naturally passes through the gastrointestinal tract for the treatment of constipation". FDA records list 3 510(k) clearances for Vibrant, Ltd., from to . As of , FDA records show no recalls naming K223031.

Clearance record

Decision date
Received
(106 days to decision)
Product code
QTN Orally Ingested Transient Device For Constipation
Regulation
21 CFR 876.5940
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Vibrant, Ltd. Hakochav P.O. Box 516, Yokneam, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QTN

Trailing 12 months

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

FDA records show no clearances under product code QTN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QTN, 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