# K212445: freeflex+ Transfer Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Kabi AG
- Decided: Jun 1, 2022 after 300 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 K910793 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201415: Vial2Bag Advanced 20mm Admixture Device, West Pharmaceutical Services Az, Inc. (2020) Summary page 5.

## Indications for use
The freeflex@+ Transfer Adapter is indicated for reconstituting and/or admixing a drug in a vial with a 20mm closure and the transfer of the drug into the freeflex@+ IV Bag prior to administration to the patient. The device may be used for pediatric (newborn to 21 years) and adult populations.

Source page: https://510kreport.com/device/K212445
Methodology: https://510kreport.com/methodology