# K183262: EsoCheck CCD Cell Collection Device

- Pathway: 510(k) (Traditional)
- Applicant: Lucid Diagnostics, Inc.
- Decided: Jun 21, 2019 after 210 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: 1 generation back to K911588 (1992). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911588: Brandt Esophageal Cytology Balloon, Wilson-Cook Medical, Inc. (1992) Summary page 4.

## Most influential descendants
- K210137: EsoCheck Cell Collection Device (2021), 2 descendants of its own
- K222366: EsoCheck Cell Collection Device (2022), 1 descendant of its own
- K230339: EsoCheck Cell Collection Device (2023), 0 descendants of its own

## Indications for use
The EsoCheck CCD Cell Collection Device is indicated for use in the collection and retrieval of surface cells of the esophagus in the general population of adults, 22 years of age and older.

Source page: https://510kreport.com/device/K183262
Methodology: https://510kreport.com/methodology