# K981184: Sharptrack Reusable Sharps Container

- Pathway: 510(k) (Traditional)
- Applicant: Bfi- Medical Waste Systems
- Decided: Jun 22, 1998 after 82 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
Used within health care settings (i.e., medical, dental, veterinarian, or other health care facility) for the collection of used disposable sharps. Containers are supplied to the health care facilities by BFI representatives. Containers are used by health care providers at the point of disposal where potentially infectious sharps’ waste is generated.

Source page: https://510kreport.com/device/K981184
Methodology: https://510kreport.com/methodology