Cleared Abbreviated

K131087 - SHARPSTANK REUSABLE SHARPS CONTAINER

K131087 is an FDA 510(k) clearance for SHARPSTANK REUSABLE SHARPS CONTAINER, manufactured by Rehrig Pacific Company. The device is a Class 2 General Hospital device with product code MMK cleared through the Abbreviated 510(k) pathway after a 85-day FDA review.

K131087 · Rehrig Pacific Company · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
85d
Days
Class 2
Risk

K131087 is an FDA 510(k) clearance for the SHARPSTANK REUSABLE SHARPS CONTAINER. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Rehrig Pacific Company (Brentwood, US). The FDA issued a Cleared decision on July 12, 2013 after a review of 85 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K131087

510(k) Number K131087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2013
Decision Date July 12, 2013
Days to Decision 85 days
Submission Type Abbreviated
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
44d faster than avg
Panel avg: 129d · This submission: 85d
Pathway characteristics
Standards-based clearance path.

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 K131087.
STERICYCLE SHARPS MANAGEMENT SERVICE REUSABLE SHARPS CONTAINER, 2 GALLON, RED, STERICYCLE SHARPS MANAGEMENT SERVICES REU
K132007 · Stericycle, Inc. · Dec 2013
SHARPSOLOGY 2
K133031 · Industrial Water Solutions, Inc. · Nov 2013
SHARPSCAN
K123807 · Medical Engineering Development Solutions, Inc. · Jul 2013
OAK RIDGE PRODUCTS SHARP CONTAINER
K130281 · Oak Ridge Products, LLC · Jun 2013
SHARPS TANK REUSABLE SHARPS CONTAINER
K111085 · Rehrig Pacific Company · Apr 2012
BD RECYKLEEN SHARPS COLLECTORS
K112774 · Becton, Dickinson and Company · Mar 2012
K131087 · SHARPSTANK REUSABLE SHARPS CONTAINER
Download PDF FDA Summary Rehrig Pacific Company