Cleared Abbreviated

K130281 - OAK RIDGE PRODUCTS SHARP CONTAINER

K130281 is an FDA 510(k) clearance for OAK RIDGE PRODUCTS SHARP CONTAINER, manufactured by Oak Ridge Products, LLC. The device is a Class 2 General Hospital device with product code MMK cleared through the Abbreviated 510(k) pathway after a 136-day FDA review.

K130281 · Oak Ridge Products, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
136d
Days
Class 2
Risk

K130281 is an FDA 510(k) clearance for the OAK RIDGE PRODUCTS SHARP CONTAINER. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Oak Ridge Products, LLC (Mchenry, US). The FDA issued a Cleared decision on June 21, 2013 after a review of 136 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 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.

View all Oak Ridge Products, LLC devices

FDA 510(k) Submission Details - K130281

510(k) Number K130281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2013
Decision Date June 21, 2013
Days to Decision 136 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 129d · This submission: 136d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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 42
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K130281.
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
SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS
K980490 · Sage Products, Inc. · Feb 1998
POINT OF USE II SHARPS-A-GATOR
K964387 · Graphic Controls Corp. · Mar 1997