# K181393: Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP

- Pathway: 510(k) (Traditional)
- Applicant: Valmed S.R.L.
- Decided: Feb 15, 2019 after 262 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: 4 generations back to K932477 (1994). 5 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101412: Eva TPN Bag, Valmed S.R.L. (2011) Summary page 4.

## Most influential descendants
- K223674: eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) (2023), 2 descendants of its own
- K201936: SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL (2021), 2 descendants of its own
- K241442: eZSURE™ Empty Fluid Container with ProSeal™ Injection Site (2024), 1 descendant of its own
- K251980: ClaveQS™ Bag (2026), 0 descendants of its own
- K252094: eZSURE™ Empty Fluid Container (2025), 0 descendants of its own

## Indications for use
The Empty EVA Bag is an 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

Source page: https://510kreport.com/device/K181393
Methodology: https://510kreport.com/methodology