Cleared Abbreviated

K130281 - OAK RIDGE PRODUCTS SHARP CONTAINER (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

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

Submission Details

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
8d slower than avg
Panel avg: 128d · This submission: 136d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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 111
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K130281.
Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)
K253222 · Zhejiang Gongdong Medical Technology Co., Ltd. · Dec 2025
PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)
K251874 · Pureway Compliance, Inc. · Oct 2025
Community Containers (Flap and Daisy)
K252637 · Keter Canada, Inc. · Oct 2025
PureWay 1.4 Quart Sharps Collector
K231484 · Pureway Compliance, Inc. · Sep 2023
Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421
K222906 · Ningbo Maxcon Medical Technology Co., Ltd. · Jun 2023
Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324)
K222905 · Ningbo Maxcon Medical Technology Co., Ltd. · Jun 2023