# K203674: B Dispensing Line

- Pathway: 510(k) (Traditional)
- Applicant: Aea Srl
- Decided: Sep 27, 2021 after 285 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: 6 generations back to K903493 (1991). 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)
- K152441: KIRO Set, Kiro Robotics S.L. (2015) Summary page 4.

## Indications for use
B Recon Line is intended for transfer of solvent from IV bag to a vial with powder drug to be reconstituted, through the APOTECAbag automated system. B Double Filling Line is intended for the transfer of solvent from a bag and liquid drug from a vial to a bag through the APOTECAbag automated system. B Filling Line is intended for transfer of drug from a vial to a bag through the APOTECAbag automated system. B Recon Line with needle is intended for transfer of solvent from a bag to a vial with powder drug to be reconstituted, through the APOTECAbag automated system. B Double Filling Line with vial needle is intended for the transfer of solvent from a bag and liquid drug from a bottle to a bag through the APOTECAbag automated system. B Filling Line for bag is intended for transfer of drug from a bag to another bag through the APOTECAbag automated system. B Dispensing Line devices are only to be used with APOTECAbag pharmacy compounding device. These devices are not to be used for the compounding of chemotherapy and oncology drugs.

Source page: https://510kreport.com/device/K203674
Methodology: https://510kreport.com/methodology