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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MMK Container, Sharps

All 94
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K130281.
SHARPSOLOGY 2
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SHARPSCAN
K123807 · Medical Engineering Development Solutions, Inc. · Jul 2013
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SHARPS TANK REUSABLE SHARPS CONTAINER
K111085 · Rehrig Pacific Company · Apr 2012
BD RECYKLEEN SHARPS COLLECTORS
K112774 · Becton, Dickinson and Company · Mar 2012
SHARPS CONTAINER
K110262 · Noble Marketing · Apr 2011

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.