# K961928: Biomedix I.V. Extension Line W/ Stopcock Model B50-102/B51-102

- Pathway: 510(k) (Traditional)
- Applicant: Biomedix, Inc.
- Decided: Sep 16, 1996 after 122 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.
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. The FDA summary names its predicate without a number.
- (no number) Baxter PHARMASEAL K52 NOVEX Three-Way Stopcock with Extension Tube: named in the summary without a submission number
- (no number) Medex Extension Set - 12" Extension with "Y" Injection Site: named in the summary without a submission number
- (no number) McGaw - G0719 I.V. Extension Set, Female and Needle Adapter: named in the summary without a submission number
- (no number) McGaw - G0726 I.V. Extension Set with (2) Injection Sites: named in the summary without a submission number
- (no number) McGaw - G0716 I.V. Extension Set with (2) Injection Sites with check valve and flashtube: named in the summary without a submission number

## Indications for use
The I.V. Extension Line Assembly with Stopcock is attached to the Primary I.V. to facilitate two advantages. One, is to add extra length between the I.V. Supply and the Patient. A second, is to provide additional supply ports for the administration of alternate solutions and special drugs that are administered intravenously. A four-way stopcock offers selection of the fluid types and sources. Biomedix is offering two models, one with a standard Needle-Type Injection Site at the Outlet and a second with a Blunt Cannula (Needleless) Type Injection Site at the outlet. This product would be used by Nurses and Paramedics in prehospital, emergency room and field situations.

Source page: https://510kreport.com/device/K961928
Methodology: https://510kreport.com/methodology