# K101958: Amsino I.V. Administration and Extension Sets

- Pathway: 510(k) (Special)
- Applicant: Amsino International, Inc.
- Decided: Sep 29, 2010 after 79 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: 2 generations back to K973107 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973107: Amsino I.V. Administration Set, Amsino Intl., Inc. (1997) Summary page 1.
- K093773: Amsino I.V. Administration Set, AMSAFE3 I.V Administration Set, Extension Sets, Amsino International, Inc. (2010) Summary page 1.

## Most influential descendants
- K222766: Disposable Extension Set (2024), 0 descendants of its own

## Indications for use
The AMSINO® I.V. ADMINISTRATION EXTENSION 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/K101958
Methodology: https://510kreport.com/methodology