# K983750: Deroyal Industries, Inc Tracecart Sharps Collection Container

- Pathway: 510(k) (Traditional)
- Applicant: Deroyal Industries, Inc.
- Decided: Nov 30, 1998 after 38 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) Baxter: named in the summary without a submission number
- (no number) Sage Products: named in the summary without a submission number
- (no number) Devon Industries: named in the summary without a submission number

## Indications for use
The DeRoyal Industries Inc. TraceCart Sharps Collection Container is to be used by generators of medical waste in any health care setting where the safe collection and disposal of contaminated waste and medical sharps is required, such as in hospitals, doctors’ offices, and other health care settings.

Source page: https://510kreport.com/device/K983750
Methodology: https://510kreport.com/methodology