# K251874: PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)

- Pathway: 510(k) (Traditional)
- Applicant: Pureway Compliance, Inc.
- Decided: Oct 14, 2025 after 118 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: 4 generations back to K943134 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151249: Pureway Sharps Collector 1.2 Gallon,  Pureway Sharps Collector 2 Gallon, Pureway Sharps Collector 3 Gallon, Pureway Compliance, Inc. (2015) Summary page 5.

## Indications for use
The PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal(800011 800012, 800013) are single-use, disposable, non-sterile containers intended to be used for healthcare purposes for the safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets, and blood needles. The target population is trained healthcare professionals.

Source page: https://510kreport.com/device/K251874
Methodology: https://510kreport.com/methodology