# K254123: Ecomed Disposable Administration Sets

- Pathway: 510(k) (Abbreviated)
- Applicant: Ecomed Solutions, LLC
- Decided: Sep 11, 2026 after 266 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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 K060082 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K234129: Ecomed Disposable Administration Sets, Ecomed Solutions, LLC (2024) Summary page 5.

## Indications for use
Ecomed Disposable Administration sets are used to transfer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

Source page: https://510kreport.com/device/K254123
Methodology: https://510kreport.com/methodology