# K233974: Mucosal Impedance Measurement System

- Pathway: 510(k) (Traditional)
- Applicant: Alandra Medical Sapi DE CV
- Decided: Sep 6, 2024 after 266 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
Longest line of descent: 3 generations back to K820441 (1982). 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)
- DEN180067: Mucosal Integrity Conductivity (MI) Test System, Diversatek Healthcare, Inc. (2019) Summary page 5.
- K213258: Nasogastric Feeding Tubes - ENFit Port - PVC, Cair Lgl (2022) Summary page 5.

## Indications for use
The Mucosal Impedance Measurement System is indicated for use by medical personnel trained in the usage of enteral feeding tubes for the treatment of adult patients requiring gastric decompression or enteral feeding for the delivery nutrition, fluids, and medications to the patient from an enteral feeding syringe or feedings set designed with ENFit connectors. The measurements of the Mucosal Impedance Measurement System are collected in patients indicated for enteral feeding. This product is single use for no longer than 24 hours. The Mucosal Impedance Measurement System is equipped with sensors designed to collect and display real time and continuous gastric reactance “XL” measurements. The device is not for use as a sole diagnostic screening tool and is restricted to prescription use in a hospital environment.

Source page: https://510kreport.com/device/K233974
Methodology: https://510kreport.com/methodology