# K980003: M500-100 Sharps Container

- Pathway: 510(k) (Traditional)
- Applicant: Imagination Medical, Inc.
- Decided: Mar 13, 1998 after 70 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 K943575 (1994). 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)
- K943575: B-D Guardian Nestable Sharps Collectors, Bd Becton Dickinson Vacutainer Systems Preanalytic (1994) Summary page 1.
- (no number) Sage Sharps Phlebotomy Container #8900MW: named in the summary without a submission number

## Indications for use
The M500-100 sharps container is designed to hold up to30 syringes from 1 to 5 cc in size. This container is intended for use by trained medical personnel in a medical clinic setting for the safe disposal of hazardous sharps.

Source page: https://510kreport.com/device/K980003
Methodology: https://510kreport.com/methodology