# K132011: Apoteca Dug Compounding Dosing Device,Apoteca I.V. Transfer Set

- Pathway: 510(k) (Abbreviated)
- Applicant: Aea Srl
- Decided: Mar 21, 2014 after 263 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: 4 generations back to K883614 (1988). 10 ancestors in all.
No later device cites it as a predicate yet.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110771: BD Single Use, Hypodermic Syringe, Becton, Dickinson and Company (2011) Summary page 1.
- K832347: Twofer Needle, Baxa Corp., Sub. of Cook Group, Inc. (1983) Summary page 1.
- K071741: Tevadaptor, Closed Drug Reconstitution and Transfer System, Migada Plant (2007) Summary page 1.
- K980381: Phaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration Devices. C80 Infusion Adapter, A10 Pro, Carmel Pharma Ab. (1998) Summary page 1.
- K002705: Exacta-Mix 2400 Compounding System, Model Exacta-Mix 2400, Baxa Corp. (2001) Summary page 1.

## Cited in the summary but kept off the family tree
- K980987: Becton Dickinson Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The APOTECA Drug Compounding Dosing Device is indicated for use by pharmacists or other healthcare professionals for the preparation of chemotherapy drugs, for the transfer of drug from vials to IV bag for infusion. The drug transfer through the device can be performed manually or through an automatic pharmacy compounding system. The specific assembly configuration of the needle allows a robotic arm to manage the device and an automatic dosing device to transfer drug from a vial to a bag by applying pressure on the syringe plunger. The APOTECA Drug Compounding Dosing Device is intended for use with APOTECAchemo automatic compounding system or for manual drug compounding. The APOTECA I.V. Transfer Set is a non-vented infusion set indicated to be used as a connecting part between the IV bag and an external IV line when the drug preparation is performed through an automatic pharmacy compounding system. The APOTECA I.V. Transfer Set is intended for use with APOTECAchemo automatic compounding system.

Source page: https://510kreport.com/device/K132011
Methodology: https://510kreport.com/methodology