FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)
K Number: K251874
·
Decision Oct 14, 2025
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
112
Applicant Total
3
Review Days
118
Basic Information
- Device Name
- PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)
- K Number
- K251874
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pureway Compliance, Inc.
- Date Received
- June 18, 2025
- Decision Date
- October 14, 2025
- Product Code
- MMK
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MMK | Container, Sharps | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MMK), ordered by most recent decision date.
Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong
FDA 510(k)
FDA Class 2
·General Hospital
Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)
FDA 510(k)
FDA Class 2
·General Hospital
Community Containers (Flap and Daisy)
FDA 510(k)
FDA Class 2
·General Hospital
PureWay 1.4 Quart Sharps Collector
FDA 510(k)
FDA Class 2
·General Hospital
Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421
FDA 510(k)
FDA Class 2
·General Hospital
Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324)
FDA 510(k)
FDA Class 2
·General Hospital