# K111217: Additive Cap

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jun 14, 2011 after 43 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: 1 generation back to K760880 (1976). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K760880: Additive Cap (2B8905), Travenol Laboratories, S.A. (1976) Summary page 1.

## Most influential descendants
- K190305: Additive Cap (2019), 0 descendants of its own

## Indications for use
Additive Cap is indicated for use on the medication port of VIAFLEX and AVIVA containers to provide visual evidence that medication has been added.

Source page: https://510kreport.com/device/K111217
Methodology: https://510kreport.com/methodology