# K231484: PureWay 1.4 Quart Sharps Collector

- Pathway: 510(k) (Traditional)
- Applicant: Pureway Compliance, Inc.
- Decided: Sep 14, 2023 after 114 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). 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)
- K130281: Oak Ridge Products Sharp Container, Oak Ridge Products, LLC (2013) Summary page 4.

## Indications for use
PureWay Compliance 1.4 Quart Sharps Collector Container is single-use, disposable, non-sterile and intended to be used for healthcare purposes for safe containment and disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target user is for healthcare professionals.

Source page: https://510kreport.com/device/K231484
Methodology: https://510kreport.com/methodology