# K242126: I.V. Administration Set

- Pathway: 510(k) (Special)
- Applicant: Bq Plus Medical Co., Ltd.
- Decided: Aug 22, 2024 after 34 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Dec 31, 2025 · Class II · Z-1366-2026: Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or break duri

## 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/K242126
Methodology: https://510kreport.com/methodology