# K151249: Pureway Sharps Collector 1.2 Gallon,  Pureway Sharps Collector 2 Gallon, Pureway Sharps Collector 3 Gallon

- Pathway: 510(k) (Traditional)
- Applicant: Pureway Compliance, Inc.
- Decided: Sep 4, 2015 after 115 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 K943134 (1994). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132476: Sharps Container, Grp & Associates (2014) Summary page 4.

## Most influential descendants
- K251874: PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) (2025), 0 descendants of its own

## Indications for use
The PureWay® Sharps Collector Container is a disposable infectious waste container in 1.2 gallon, 2 gallon and 3 gallon sizes, intended for use in a healthcare setting. The PureWay® Sharps Collector Container will be ultimately destroyed through incineration. The empty device, as it sits, is a red container that measures 10.75” x 6” x 7.27” and weighs 7oz. The aperture includes an insert which limits the opening to 1.25 inches in diameter. The intended use of the vertical entry, single use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. The container is intended to be used in a healthcare setting. The empty device, as it sits, is a red container that measures 10.75” x 6” x 11.15” and weighs 1lb 1oz. The aperture includes an insert which limits the opening to 1.25 inches in diameter. The intended use of the vertical entry, single use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. The container is intended to be used in a healthcare setting. The empty device, as it sits, is a red container that measures 10.75” x 6” x 15.73” and weighs 2 lbs. The aperture includes an insert which limits the opening to 1.25 inches in diameter. The intended use of the vertical entry, single use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. The container is intended to be used in a healthcare setting.

Source page: https://510kreport.com/device/K151249
Methodology: https://510kreport.com/methodology