# K223645: I.V. Administration Set, I.V. Extension Set

- Pathway: 510(k) (Traditional)
- Applicant: Bq Plus Medical Co., Ltd.
- Decided: May 18, 2023 after 163 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 K925465 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111351: Truecare Biomedix Intravascular Administration Set, Truecare Biomedix Extension Set, Us Infusion Dba Truecare Biomedix (2011) Summary page 5.

## Indications for use
The I.V. Administration Set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features. The I.V. Extension Set may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient.

Source page: https://510kreport.com/device/K223645
Methodology: https://510kreport.com/methodology