Lucid Diagnostics, Inc.

FDA Regulatory Profile

Lucid Diagnostics, Inc. appears in FDA public data with 2 recalls, 4 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1899-2024, Class II) was initiated on April 24, 2024. Its most recent 510(k) clearance was granted on February 24, 2023.

Summary

Total Recalls
2
510(k) Clearances
4
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1899-2024Class IIBrand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch) Model/Catalog Number:April 24, 2024
Z-1900-2024Class IIBrand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch) Model/Catalog Number:April 24, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K230339EsoCheck Cell Collection DeviceFebruary 24, 2023
K222366EsoCheck Cell Collection DeviceOctober 26, 2022
K210137EsoCheck Cell Collection DeviceFebruary 18, 2021
K183262EsoCheck CCD Cell Collection DeviceJune 21, 2019