# K973107: Amsino I.V. Administration Set

- Pathway: 510(k) (Traditional)
- Applicant: Amsino Intl., Inc.
- Decided: Oct 2, 1997 after 44 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
No predicates in its family tree.
17 later devices descend from it; 4 cite it directly.
2 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K120685: Zyno Medical Administration Set (2012), 12 descendants of its own
- K151151: U & U Intravascular Administration Set (2015), 5 descendants of its own
- K093773: Amsino I.V. Administration Set, AMSAFE3 I.V Administration Set, Extension Sets (2010), 2 descendants of its own
- K232316: DEKA Infusion System, DEKA Administration Set (2024), 1 descendant of its own
- K230343: ProSeal™ Closed System Administration Set (2023), 1 descendant of its own

## Indications for use
AMSINO INTRAVASCULAR ADMINISTRATION SET IS A DEVICE INTENDED TO ADMINISTER FLUIDS FROM A CONTAINER TO A PATIENT'S VASCULAR SYSTEM THROUGH A CATHETER INSERTED INTO A VEIN.

Source page: https://510kreport.com/device/K973107
Methodology: https://510kreport.com/methodology