# K192770: S dispensing line

- Pathway: 510(k) (Traditional)
- Applicant: Aea Srl
- Decided: Dec 17, 2020 after 444 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- 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 K002705 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022523: Rapid-Fill Tubeset, Model 90005, Baxa Corp. (2002) Summary page 4.
- K002705: Exacta-Mix 2400 Compounding System, Model Exacta-Mix 2400, Baxa Corp. (2001) Summary page 4.

## Indications for use
The S Dispensing Line is intended for transfer of liquid drug from bag to syringes through the APOTECAsyringe automated system. The device is used inside an automatic system APOTECAsyringe that tightens the tube with the syringe, while the connection with the bag is done manually. The transfer of liquid takes place by depression through the mechanical action on the piston of the syringe of a manipulator equipped with a gripping device.

Source page: https://510kreport.com/device/K192770
Methodology: https://510kreport.com/methodology