Cleared Traditional

K131708 - BWCSH-1 SHARPS CONTAINER

K131708 is an FDA 510(k) clearance for BWCSH-1 SHARPS CONTAINER, manufactured by Bradford Wright Companies, Inc.. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K131708 · Bradford Wright Companies, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
272d
Days
Class 2
Risk

K131708 is an FDA 510(k) clearance for the BWCSH-1 SHARPS CONTAINER. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Bradford Wright Companies, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on March 10, 2014 after a review of 272 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K131708

510(k) Number K131708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2013
Decision Date March 10, 2014
Days to Decision 272 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
143d slower than avg
Panel avg: 129d · This submission: 272d
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 98
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K131708.
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
SHARPS CONTAINER
K132476 · Grp & Associates · May 2014
MEDLINE SHARPS CONTAINER
K132767 · Medline Industries, Inc. · Feb 2014
ECOSHIP DISPOSABLE SHARPS CONTAINER, ECOSHIP DISPOSABLE SHARPS CONTAINER
K132792 · Daniels Sharpsmart, Inc. · Jan 2014
STERICYCLE SHARPS MANAGEMENT SERVICE REUSABLE SHARPS CONTAINER, 2 GALLON, RED, STERICYCLE SHARPS MANAGEMENT SERVICES REU
K132007 · Stericycle, Inc. · Dec 2013
K131708 · BWCSH-1 SHARPS CONTAINER
Download PDF FDA Summary Bradford Wright Compa…