# K151423: APEX Compounding System Transfer Set

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Feb 19, 2016 after 267 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002705 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002705: Exacta-Mix 2400 Compounding System, Model Exacta-Mix 2400, Baxa Corp. (2001) Summary page 5.

## Recalls of this device
- Jun 4, 2018 · Class II · Z-2343-2018: There is a potential for valves on the 26-Lead Transfer Set to be incorrectly oriented. When a transfer set with an incorrectly oriented valve is installed on the system, there is potential for uninte

## Indications for use
The APEX Transfer Set is intended to be used with the APEX Compounding System. The administration sets are to be used in a sterile compounding environment within a pharmacy to provide a fluid path for the compounding of ingredients from multiple source containers into a final solution.

Source page: https://510kreport.com/device/K151423
Methodology: https://510kreport.com/methodology