510(k) clearance

Ecomed Disposable Administration Sets

FDA 510(k) source

510(k) number

K254123

Applicant

Ecomed Solutions, LLC

Decision date

Sep 11, 2026

Date received

Dec 19, 2025

Decision

Substantially Equivalent

Clearance type

Abbreviated

Product code

FPA

Device type

Set, Administration, Intravascular

Device class

Class II

Regulation

21 CFR 880.5440

Advisory committee

General Hospital

Statement or summary

Summary

Third party

N

Location

Lindenhurst, IL, US