# K190305: Additive Cap

- Pathway: 510(k) (Traditional)
- Applicant: International Medical Industries, Inc.
- Decided: Apr 30, 2019 after 77 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: 2 generations back to K760880 (1976). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111217: Additive Cap, Baxter Healthcare Corp (2011) Summary page 4.

## Indications for use
The Additive Port Cap is indicated for use on the medication port of Baxter VIAFLEX, Baxter INTRAVIA, Baxter AVIVA, and Baxter ALL-IN-ONE EVA containers to provide both visual evidence that medication has been added and tamper evidence once the device is closed.

Source page: https://510kreport.com/device/K190305
Methodology: https://510kreport.com/methodology