# K192375: Intellifuse Administration and Intellifuse Blood Administration Sets

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Sep 18, 2020 after 385 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: 7 generations back to K030467 (2003). 16 ancestors in all.
No later device cites it as a predicate yet.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160870: Hospira Administration Sets, Hospira, Inc. (2016) Summary page 4.

## Indications for use
Intellifuse™ Administration Sets are indicated for the delivery of fluids from a container to a patient’s vascular system. Intellifuse™ Blood Administration Sets are indicated for the delivery of fluids including but not limited to blood and blood products from a container to a patient’s vascular system.

Source page: https://510kreport.com/device/K192375
Methodology: https://510kreport.com/methodology