# K250459: DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution

- Pathway: 510(k) (Traditional)
- Applicant: Technoflex Sas.
- Decided: Apr 18, 2025 after 59 days
- Product code: KPE (Container, I.V.)
- Device class: 2
- Regulation: 21 CFR 880.5025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K932477 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201936: SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL, Gilero, LLC (2021) Summary page 5.

## Indications for use
The TECHNOFLEX DMRX Empty solution container is empty container used for administration of intravenous solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique. After use the bag is discarded.

Source page: https://510kreport.com/device/K250459
Methodology: https://510kreport.com/methodology