# K203450: EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)

- Pathway: 510(k) (Traditional)
- Applicant: Capnostics, LLC
- Decided: May 4, 2021 after 162 days
- Product code: EOX (Esophagoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4710
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K934193 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934193: Cell-Mate (TM) Mass Cytology-Cellular Retrieval Syst, Biosearch Medical Products, Inc. (1993) Summary page 4.
- K142695: Cytosponge Cell Collection Device, Covidien, LLC (2014) Summary page 4.
- K152794: Cytosponge Cell Collection Device, Covidien, LLC (2016) Summary page 4.
- K181020: Cytosponge Cell Collection Device, Covidien, LLC (2018) Summary page 4.

## Recalls of this device
- Apr 24, 2024 · Class II · Z-1900-2024: The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gastroesophageal junctio
- Apr 24, 2024 · Class II · Z-1899-2024: The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gastroesophageal junctio

## Indications for use
The gathering and recovery of cells and cellular material from the mucosa in the esophagus for cytological and histological analyses.

Source page: https://510kreport.com/device/K203450
Methodology: https://510kreport.com/methodology