# DEN180067: Mucosal Integrity Conductivity (MI) Test System

- Pathway: De Novo (Direct)
- Applicant: Diversatek Healthcare, Inc.
- Decided: Dec 23, 2019 after 371 days
- Product code: QIS (Esophageal, Mucosal, Electrical Characterization)
- Device class: 2
- Regulation: 21 CFR 876.1450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K233974: Mucosal Impedance Measurement System (2024), 0 descendants of its own
- K230056: MiVu™ Esophageal Endo Cap (2023), 0 descendants of its own

## Indications for use
The Mucosal Integrity Conductivity Test System is indicated for use by gastroenterologists, surgeons, and medically trained personnel during an endoscopy to obtain a real time measurement of esophageal epithelial impedance. The device is not for use as a sole diagnostic screening tool.

Source page: https://510kreport.com/device/DEN180067
Methodology: https://510kreport.com/methodology