Cleared Traditional

PUREWAY SHARPS COLLECTOR 1.2 GALLON, PUREWAY SHARPS COLLECTOR 2 GALLON, PUREWAY SHARPS COLLECTOR 3 GALLON (K151249) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 20
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K151249.
Maxcon Sharps Container
K180984 · Ningbo Maxcon Medical Technology Co., Ltd. · Jan 2019
HealthBeacon HB2 Sharps Bin
K172719 · Healthbeacon, Ltd. · May 2018
MEDLINE SHARPS CONTAINERS
K143693 · Medline Industries, Inc. · Nov 2015
MEDLINE SHARPS CONTAINER
K132767 · Medline Industries, Inc. · Feb 2014
BD RECYKLEEN SHARPS COLLECTORS
K112774 · Becton, Dickinson and Company · Mar 2012