# K960982: Monoject Blunt I.V. Access Cannula/Monoject Hypodermic Syringe with Blunt I.V. Access Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Sherwood Medical Co.
- Decided: Dec 23, 1996 after 287 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) B-D Interlink Syringe Cannula: named in the summary without a submission number
- (no number) Monoject Lifeshield Blunt Cannula: named in the summary without a submission number
- (no number) Monoject Lifeshield Blood Collection Device: named in the summary without a submission number

## Most influential descendants
- K980062: Monojectt Bluntip I.V. Access Cannula with Vial Access Pin Device (1998), 0 descendants of its own

## Indications for use
It is used to provide access to pre-pierced IV line injection sites and pre-pierced medication vials.

Source page: https://510kreport.com/device/K960982
Methodology: https://510kreport.com/methodology