# K964989: CDC Vial and Bag Access Pin (CDC-P-1/P-2/P-3/P-4/P-5)

- Pathway: 510(k) (Traditional)
- Applicant: Critical Device Corp.
- Decided: Apr 2, 1997 after 110 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) Needle-Free Dispensing Pin: named in the summary without a submission number

## Indications for use
For aspiration or injection of medical from inverted muitidose vials and bags For use as part of a program to reduce the occurrence of needle stick injuries and the associated transmission of blood borme pathogens such as HIV and HBV. For use up to 24 hours, or in accordance with current guidelines of 1V therapy. For use with standard luer taper connections. For single patient use.

Source page: https://510kreport.com/device/K964989
Methodology: https://510kreport.com/methodology