# K955595: Safeline Multidose Vial Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Mcgaw, Inc.
- Decided: Mar 6, 1996 after 89 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- 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 InterLink® System Universal Vial Adapter: named in the summary without a submission number

## Indications for use
The SafeLine Multidose Vial Adapter is intended for multiple withdrawals of drug solution from standard size drug vial solid stoppers. The spike portion of the SafeLine Multidose Vial Adapter is inserted into the drug vial solid stopper and the drug solution is withdrawn using a blunt plastic cannula connected to a syringe. The fluid is withdrawn into the syringe through the blunt plastic cannula inserted into the injection site portion of the SafeLine Multidose Vial Adapter. The drug solution in the syringe can then be transferred to an I.V. administration set with a pre-slit septum injection site for administration of the drug solution to the patient. The SafeLine Multidose Vial Adapter replaces use of a traditional metal hypodermic needle to provide needlefree access to drug vials. Thus, eliminating the potential for accidental needlestick injury.

Source page: https://510kreport.com/device/K955595
Methodology: https://510kreport.com/methodology