# K083511: Enviro Sharp Solutions 3

- Pathway: 510(k) (Traditional)
- Applicant: Industrial Water Solutions, Inc.
- Decided: Mar 3, 2009 after 97 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: 3 generations back to K964387 (1997). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953797: Sharps Disposal Containers, Bemis Mfg. Co. (1995) Summary page 2.
- K020664: Sterisharp 3-Gallon RSDC, Model RSDC3G, Sterilogic Waste Systems, Inc. (2002) Summary page 1.

## Most influential descendants
- K131087: Sharpstank Reusable Sharps Container (2013), 0 descendants of its own

## Indications for use
The container is intended for use by healthcare providers, such as hospitals, laboratories, medical clinics, veterinary clinics and other facilities where needles are generated. 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.

Source page: https://510kreport.com/device/K083511
Methodology: https://510kreport.com/methodology