# K955594: Safeline I.V. Bag Access Device

- 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) McGaw Safeline Injection Site: named in the summary without a submission number

## Indications for use
The SafeLine 1.V. Bag Access Device is intended for multiple withdrawals of fluid from the set port of standard 1.V. bags. The spike portion of the SafeLine 1.V. Bag Access Device is inserted into the I.V. bag set port and the fluid is withdrawn using a blunt plastic cannula connected to a syringe. The fluid is withdrawn into the syringe through the blunt plastic cannula inserted into the injection site portion of the SafeLine 1.V. Bag Access Device. The fluid in the syringe can then be used for performing “I.V. pushes,” to flush patient 1.V. lines, or other pharmaceutical uses. The SafeLine 1.V. Bag Access Device replaces the use of a traditional metal hypodermic needle to provide needlefree access to I.V. Bags. Thus, eliminating the potential for accidental needlestick injury.

Source page: https://510kreport.com/device/K955594
Methodology: https://510kreport.com/methodology