# K062984: Medline Hypodermic Needles

- Pathway: 510(k) (Abbreviated)
- Applicant: Medline Industries, Inc.
- Decided: Nov 13, 2006 after 45 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Medline Disposable Sterile Hypodermic Needles are intended for use to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin

Source page: https://510kreport.com/device/K062984
Methodology: https://510kreport.com/methodology