# K190149: Vial Adapter Ø20 mm

- Pathway: 510(k) (Traditional)
- Applicant: Avenir Performance Europeenne Medical (Apem)
- Decided: Oct 15, 2019 after 259 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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 K963583 (1996). 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)
- K171796: Vial Adapter 15mm, Medimop Medical Project, Ltd. (2017) Summary page 5.

## Indications for use
Vial Adapter Ø20mm are indicated for the transfer and mixing of drugs contained in vials.

Source page: https://510kreport.com/device/K190149
Methodology: https://510kreport.com/methodology