# K213513: Vented Vial Adapter 20mm

- Pathway: 510(k) (Traditional)
- Applicant: West Pharma. Services IL, Ltd.
- Decided: Aug 31, 2022 after 302 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: 4 generations back to K925401 (1993). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160503: Vented Vial Adapter Transfer Device - 13mm, Medimop Medical Projects, Ltd. (2016) Summary page 4.

## Indications for use
Transfer of drugs contained in a vial.

Source page: https://510kreport.com/device/K213513
Methodology: https://510kreport.com/methodology