K251874 is an FDA 510(k) clearance for the PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013). This device is classified as a Container, Sharps (Class II - Special Controls, product code MMK).
Submitted by Pureway Compliance, Inc. (Katy, US). The FDA issued a Cleared decision on October 14, 2025, 118 days after receiving the submission on June 18, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K251874 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 18, 2025 |
| Decision Date | October 14, 2025 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MMK - Container, Sharps |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |