# K252543: AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)

- Pathway: 510(k) (Traditional)
- Applicant: Amsino International, Inc.
- Decided: May 4, 2026 after 265 days
- Product code: FPA (Set, Administration, Intravascular)
- 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: 3 generations back to K832284 (1983). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120685: Zyno Medical Administration Set, Zyno Medical, LLC (2012) Summary page 5.

## Indications for use
The administration set is a device used to administer fluids from a container to a patient’s vascular system through a needle or a catheter inserted into a vein. The administration set is to be used with patients, 18 years of age or older. The administration set is to be used under direct supervision of a physician or other certified healthcare provider in healthcare facilities, including but not limited to, hospitals (outpatients only), skilled nursing facilities, and short-term acute care facilities. The administration set is also intended to be used in inpatient rehabilitation facilities and in home settings. The administration set can be used with the Zyno Z-800F and Z-800WF Infusion pumps or can be administered by gravity flow.

Source page: https://510kreport.com/device/K252543
Methodology: https://510kreport.com/methodology