Cleared Traditional

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

K251874 is an FDA 510(k) clearance for PureWay Sharps Container 1-Gal, manufactured by Pureway Compliance, Inc.. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K251874 · Pureway Compliance, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Oct 2025
Decision
118d
Days
Class 2
Risk

K251874 is an FDA 510(k) clearance for the PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013). Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Pureway Compliance, Inc. (Katy, US). The FDA issued a Cleared decision on October 14, 2025 after a review of 118 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Pureway Compliance, Inc. devices

FDA 510(k) Submission Details - K251874

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 129d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MMK Device Classification - Class 2, Special Controls

Product Code MMK Container, Sharps
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - MMK Container, Sharps

All 88
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K251874.
Huahong Sharps Container (HHR-I, HHR-II)
K260845 · Tianjin Huahong Technology Co., Ltd. · Aug 2026
Guanhong Sharps Container (GHW-1F1)
K253773 · Taizhou Huangyan Guanhong Plastic Steel Products Factory · May 2026
Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)
K253222 · Zhejiang Gongdong Medical Technology Co., Ltd. · Dec 2025
Community Containers (Flap and Daisy)
K252637 · Keter Canada, Inc. · Oct 2025
PureWay 1.4 Quart Sharps Collector
K231484 · Pureway Compliance, Inc. · Sep 2023
Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421
K222906 · Ningbo Maxcon Medical Technology Co., Ltd. · Jun 2023