# K230339: EsoCheck Cell Collection Device

- Pathway: 510(k) (Special)
- Applicant: Lucid Diagnostics, Inc.
- Decided: Feb 24, 2023 after 17 days
- Product code: EOX (Esophagoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K911588 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222366: EsoCheck Cell Collection Device, Lucid Diagnostics, Inc. (2022) Summary page 4.

## Indications for use
The EsoCheck Cell Collection Device is indicated for use in the collection and retrieval of surface cells of the esophagus in the general population of adults and adolescents, 12 years of age and older.

Source page: https://510kreport.com/device/K230339
Methodology: https://510kreport.com/methodology