# KPE: Container, I.V.

- Device class: 2; regulation: 21 CFR 880.5025; FDA's rule: 510(k) required
- FDA decisions: 117
- 510(k) review time 2021–2025: median 160 days (middle half 45–219)
- Recalls: 53 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2011: 2
- 2012: 1
- 2013: 1
- 2019: 3
- 2020: 1
- 2021: 2
- 2023: 2
- 2024: 1
- 2025: 2
- 2026: 3

## Most-cited predicates
- K983294: All-in-One Container Cat#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712 (1998), cited by 3
- K911567: Dual Compartment TPN Bag 3 Liter (1991), cited by 2
- K181393: Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP (2019), cited by 2
- K030888: Eva Empty Solution Container (2003), cited by 2
- K223674: eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) (2023), cited by 2
- K041038: Churchill Medical Dual Chamber Empty Container (2004), cited by 2
- K201936: SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL (2021), cited by 2
- K041415: Eva TPN Container (2004), cited by 2
- K101412: Eva TPN Bag (2011), cited by 2
- K830232: Decanter Models-Various (1983), cited by 1

Source page: https://510kreport.com/product-code/KPE
Data by year (CSV): https://510kreport.com/product-code/KPE.csv