Cleared Traditional

K161180 - Oak Ridge Products Sharps Containers

K161180 is an FDA 510(k) clearance for Oak Ridge Products Sharps Containers, manufactured by Oak Ridge Products, LLC. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K161180 · 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 2016
Decision
43d
Days
Class 2
Risk

K161180 is an FDA 510(k) clearance for the Oak Ridge Products Sharps Containers. 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 9, 2016 after a review of 43 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K161180

510(k) Number K161180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2016
Decision Date June 09, 2016
Days to Decision 43 days
Submission Type Traditional
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
86d faster than avg
Panel avg: 129d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. 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 K161180.
MAUSER PG II Sharps Container
K170513 · Mauzer USA, LLC · Nov 2017
Med-Tainer Single Deposit Container
K153274 · Snyder Industries, Inc. · Aug 2016
Red2Green Reusable Sharps Container
K153363 · Triumvirate Environmental, Inc. · Jul 2016
NAR Sharps Shuttle
K152340 · North American Rescue, LLC · May 2016
MEDLINE SHARPS CONTAINERS
K143693 · Medline Industries, Inc. · Nov 2015
PUREWAY SHARPS COLLECTOR 1.2 GALLON, PUREWAY SHARPS COLLECTOR 2 GALLON, PUREWAY SHARPS COLLECTOR 3 GALLON
K151249 · Pureway Compliance, Inc. · Sep 2015

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.