# K970383: Sharps Container

- Pathway: 510(k) (Traditional)
- Applicant: Custom Medical Plastics, Inc.
- Decided: Jul 3, 1997 after 150 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. The FDA summary names its predicate without a number.
- (no number) Horizontal Entry Sharps Containers manufactured by Sage Products Inc.: named in the summary without a submission number
- (no number) Horizontal Entry Sharps Containers manufactured by Sherwood Medical: named in the summary without a submission number

## Indications for use
our Horizontal Entry Sharps Containers provide a receptacle for used, contaminated medical Sharps and for enclosure during transport to ultimate disposal.

Source page: https://510kreport.com/device/K970383
Methodology: https://510kreport.com/methodology