Cleared Traditional

K141759 - OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERS

K141759 is an FDA 510(k) clearance for OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS..., 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 115-day FDA review.

K141759 · Oak Ridge Products, LLC · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
115d
Days
Class 2
Risk

K141759 is an FDA 510(k) clearance for the OAK RIDGE PRODUCTS MULTI-PURPOSE 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 October 24, 2014 after a review of 115 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K141759

510(k) Number K141759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2014
Decision Date October 24, 2014
Days to Decision 115 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
14d faster than avg
Panel avg: 129d · This submission: 115d
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 K141759.
PUREWAY SHARPS COLLECTOR 1.2 GALLON, PUREWAY SHARPS COLLECTOR 2 GALLON, PUREWAY SHARPS COLLECTOR 3 GALLON
K151249 · Pureway Compliance, Inc. · Sep 2015
MedSource Sharps Dart
K150333 · Medsource International, LLC · May 2015
B TRAVELSAVVY SHARPS CONTAINER
K140285 · Bellegrove Medical Supply, Inc. · Dec 2014
SHARPS CONTAINER
K132476 · Grp & Associates · May 2014
BWCSH-1 SHARPS CONTAINER
K131708 · Bradford Wright Companies, Inc. · Mar 2014
MEDLINE SHARPS CONTAINER
K132767 · Medline Industries, Inc. · Feb 2014

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.