# K992626: Sure-Way Reusable Sharps Container

- Pathway: 510(k) (Traditional)
- Applicant: Sure-Way Systems, Inc.
- Decided: Dec 16, 1999 after 133 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K133031: Sharpsology 2 (2013), 0 descendants of its own

## Indications for use
The Sure-Way Reusable Container is intended to be used for the disposal of contaminated medical sharps in health care facilities.

Source page: https://510kreport.com/device/K992626
Methodology: https://510kreport.com/methodology