Cleared Traditional

K153363 - Red2Green Reusable Sharps Container

K153363 is an FDA 510(k) clearance for Red2Green Reusable Sharps Container, manufactured by Triumvirate Environmental, Inc.. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K153363 · Triumvirate Environmental, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
249d
Days
Class 2
Risk

K153363 is an FDA 510(k) clearance for the Red2Green Reusable Sharps Container. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Triumvirate Environmental, Inc. (Somerville, US). The FDA issued a Cleared decision on July 26, 2016 after a review of 249 days - an extended review 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: 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 - K153363

510(k) Number K153363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2015
Decision Date July 26, 2016
Days to Decision 249 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 129d · This submission: 249d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

Acknowledge Regulatory Strategies
Allison C. Komiyama

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 K153363.
HealthBeacon HB2 Sharps Bin
K172719 · Healthbeacon, Ltd. · May 2018
MAUSER PG II Sharps Container
K170513 · Mauzer USA, LLC · Nov 2017
Med-Tainer Single Deposit Container
K153274 · Snyder Industries, Inc. · Aug 2016
Oak Ridge Products Sharps Containers
K161180 · Oak Ridge Products, LLC · Jun 2016
NAR Sharps Shuttle
K152340 · North American Rescue, LLC · May 2016
MEDLINE SHARPS CONTAINERS
K143693 · Medline Industries, Inc. · Nov 2015