# K031783: Safe-Connect Drug Dispensing Spike, Models SC 4020, SC 4015, SC 4010, SC 4005

- Pathway: 510(k) (Special)
- Applicant: Intravascular Incorporated
- Decided: Jul 1, 2003 after 21 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) Safe-Connect Vial Dispensing Spike: named in the summary without a submission number

## Indications for use
The Safe-ConnectTM Drug Dispensing Spike is a sterile, non-pyrogenic, single use device to be used in dispensing drugs from drug containers. The device is to be used by a trained healthcare professional using Aseptic Techniques for the addition of liquid diluents to powdered drug products for reconstitution, addition of liquids to concentrated liquid drugs for dilution, and/or the withdrawal of the reconstituted and liquid drug products from drug containers by the use of a standard luer tapered syringe. 'The device is indicated to allow for multiple accesses and withdrawals from the same drug container using standard hospital disinfectant solutions and procedures without the requirement of using a sterile cap to maintain lluid path integrity. 'I'he Safe-CoiinectTMDrug Ilispensing Spike may aid in the prevention of needle stick injuries.

Source page: https://510kreport.com/device/K031783
Methodology: https://510kreport.com/methodology