# K133031: Sharpsology 2

- Pathway: 510(k) (Traditional)
- Applicant: Industrial Water Solutions, Inc.
- Decided: Nov 15, 2013 after 50 days
- Product code: MMK (Container, Sharps)
- 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: 2 generations back to K943575 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992626: Sure-Way Reusable Sharps Container, Sure-Way Systems, Inc. (1999) Summary page 1.
- K072667: Sharps Away Disposable Container, Solutions, Inc. (2007) Summary page 1.

## Indications for use
The container is intended for use in healthcare settings. The container is designed to safely contain sharps prior to removal from the generating facility, during transportation and until ultimate treatment and disposal of the sharps. The container features a canteen style, vertical drop lid or a mailbox style, vertical drop lid. The container is housed in a wall mount attached to the wall. The container is translucent and can be selected in a natural or red color, The lid is a natural color. The wall mount is a natural color with a clear door. The container volume is 2.25 gallons up to the fill line. The dimensions of the container are 13.173 inches wide, 11.417 inches high and 5.993 inches in depth (front to back). The lid surface dimensions for the canteen style lid are 6.197 inches wide and 13.031 inches long. The dimensions for the mailbox style lid are 6.194 inches wide and 13.029 inches long. The diameter of the lid aperture for the canteen style, vertical drop lid is 2.135 inches. The opening of the lid aperture for the mailbox style, vertical drop lid is 2.5 inches by 9.5 inches. The dimensions of the wall mount are 12.25 inches wide, 16.625 inches high and 6.75 inches in depth (front to back).

Source page: https://510kreport.com/device/K133031
Methodology: https://510kreport.com/methodology