Cleared Traditional

K151249 - PUREWAY SHARPS COLLECTOR 1.2 GALLON, PUREWAY SHARPS COLLECTOR 2 GALLON, PUREWAY SHARPS COLLECTOR 3 GALLON

K151249 is an FDA 510(k) clearance for PUREWAY SHARPS COLLECTOR 1.2 GALLON, 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 115-day FDA review.

K151249 · Pureway Compliance, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
115d
Days
Class 2
Risk

K151249 is an FDA 510(k) clearance for the PUREWAY SHARPS COLLECTOR 1.2 GALLON, PUREWAY SHARPS COLLECTOR 2 GALLON, PURE.... Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Pureway Compliance, Inc. (Santa Monica, US). The FDA issued a Cleared decision on September 4, 2015 after a review of 115 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 - K151249

510(k) Number K151249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2015
Decision Date September 04, 2015
Days to Decision 115 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
14d faster than avg
Panel avg: 129d · This submission: 115d
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 K151249.
Oak Ridge Products Sharps Containers
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NAR Sharps Shuttle
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MEDLINE SHARPS CONTAINERS
K143693 · Medline Industries, Inc. · Nov 2015
MedSource Sharps Dart
K150333 · Medsource International, LLC · May 2015
B TRAVELSAVVY SHARPS CONTAINER
K140285 · Bellegrove Medical Supply, Inc. · Dec 2014
OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERS
K141759 · Oak Ridge Products, LLC · Oct 2014