Cleared Traditional

K083511 - ENVIRO SHARP SOLUTIONS 3

K083511 is an FDA 510(k) clearance for ENVIRO SHARP SOLUTIONS 3, 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 97-day FDA review.

K083511 · Industrial Water Solutions, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
97d
Days
Class 2
Risk

K083511 is an FDA 510(k) clearance for the ENVIRO SHARP SOLUTIONS 3. 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 March 3, 2009 after a review of 97 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 - K083511

510(k) Number K083511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2008
Decision Date March 03, 2009
Days to Decision 97 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
32d faster than avg
Panel avg: 129d · This submission: 97d
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 Peers - MMK Container, Sharps

All 98
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K083511.
SHARPSMART DISPOSABLE SHARPS CONTAINER, MODEL S2
K091736 · Daniels Corporation Pty, Inc. · Oct 2009
SHARP CHUTE
K091690 · Heathrow Scientific, LLC · Jul 2009
ISOLYSER HOME SHARPS MANAGEMENT (HSM), MODEL 800M
K090157 · Wcm Waste & Compliance Management, Inc. · May 2009
SHARPS COMPLIANCE CONTAINER
K083129 · Sharps Compliance, Inc. · Dec 2008
GONGDONG DISPOSABLE SHARP CONTAINER
K082042 · Zhejiang Gongdong Medical Plastic Factory · Sep 2008
D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP)
K081821 · Global Pathogen Solutions, Inc. · Sep 2008
K083511 · ENVIRO SHARP SOLUTIONS 3
Download PDF FDA Summary Industrial Water Solu…