# K041415: Eva TPN Container

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Aug 4, 2004 after 69 days
- Product code: KPE (Container, I.V.)
- Device class: 2
- Regulation: 21 CFR 880.5025
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K932477 (1994). 2 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983294: All-in-One Container Cat#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712, Baxter Healthcare Corp (1998) Summary page 1.

## Most influential descendants
- K101412: Eva TPN Bag (2011), 8 descendants of its own
- K181393: Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP (2019), 6 descendants of its own
- 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

## Recalls of this device
- May 25, 2022 · Class II · Z-1592-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

## Indications for use
The EVA TPN container is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The EVA TPN container can be filled either by gravity or in conjunction with automated compounding equipment.

Source page: https://510kreport.com/device/K041415
Methodology: https://510kreport.com/methodology