Cleared Traditional

K133031 - SHARPSOLOGY 2

K133031 is an FDA 510(k) clearance for SHARPSOLOGY 2, manufactured by Industrial Water Solutions, Inc.. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K133031 · Industrial Water Solutions, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2013
Decision
50d
Days
Class 2
Risk

K133031 is an FDA 510(k) clearance for the SHARPSOLOGY 2. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Industrial Water Solutions, Inc. (Roanoke, US). The FDA issued a Cleared decision on November 15, 2013 after a review of 50 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 - K133031

510(k) Number K133031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2013
Decision Date November 15, 2013
Days to Decision 50 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
79d faster than avg
Panel avg: 129d · This submission: 50d
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

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 98
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K133031.
MEDLINE SHARPS CONTAINER
K132767 · Medline Industries, Inc. · Feb 2014
ECOSHIP DISPOSABLE SHARPS CONTAINER, ECOSHIP DISPOSABLE SHARPS CONTAINER
K132792 · Daniels Sharpsmart, Inc. · Jan 2014
STERICYCLE SHARPS MANAGEMENT SERVICE REUSABLE SHARPS CONTAINER, 2 GALLON, RED, STERICYCLE SHARPS MANAGEMENT SERVICES REU
K132007 · Stericycle, Inc. · Dec 2013
SHARPSCAN
K123807 · Medical Engineering Development Solutions, Inc. · Jul 2013
SHARPSTANK REUSABLE SHARPS CONTAINER
K131087 · Rehrig Pacific Company · Jul 2013
OAK RIDGE PRODUCTS SHARP CONTAINER
K130281 · Oak Ridge Products, LLC · Jun 2013

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.