LimFlow, Inc.

FDA Regulatory Profile

LimFlow, Inc. appears in FDA public data with 1 recall, 6 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1218-2026, Class II) was initiated on December 5, 2025. Its most recent 510(k) clearance was granted on March 18, 2026.

Summary

Total Recalls
1
510(k) Clearances
6
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1218-2026Class IIBrand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23December 5, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K260188LimFlow VectorMarch 18, 2026
K251376LimFlow ARCMay 31, 2025
K242776LimFlow V-CeiverFebruary 14, 2025
K221902LimFlow VectorDecember 21, 2022
K221541LimFlow ARCAugust 31, 2022
K222083LimFlow V-CeiverAugust 9, 2022