# K980062: Monojectt Bluntip I.V. Access Cannula with Vial Access Pin Device

- Pathway: 510(k) (Traditional)
- Applicant: Davis & Geck, Inc.
- Decided: Mar 20, 1998 after 72 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K960982 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960982: Monoject Blunt I.V. Access Cannula/Monoject Hypodermic Syringe with Blunt I.V. Access Cannula, Sherwood Medical Co. (1996) Summary page 1.
- (no number) Becton Dickinson 18 gauge Hypodermic needle: named in the summary without a submission number
- (no number) Monoject gauge hypodermic needles manufactured by Sherwood Davis and Geck: named in the summary without a submission number

## Indications for use
Sherwood-Davis & Geck Monoject® BlunTip™ I.V. Access Cannula with Vial Access Pin Device is designed to provide needleless drug access. The sterile access pin is used to pre-pierce the rubber drug vial closure, facilitating direct medication access with the BlunTip* cannula. Only one access pin penetration is required to enable repeated BlunTip* cannula access. Once drawn , the medicaiton can be delivered through any pre-pierced I.V. port compatible with the BlunTip* cannula.

Source page: https://510kreport.com/device/K980062
Methodology: https://510kreport.com/methodology