Cleared Traditional

K091736 - SHARPSMART DISPOSABLE SHARPS CONTAINER, MODEL S2

K091736 is an FDA 510(k) clearance for SHARPSMART DISPOSABLE SHARPS CONTAINER, manufactured by Daniels Corporation Pty, Inc.. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K091736 · Daniels Corporation Pty, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
141d
Days
Class 2
Risk

K091736 is an FDA 510(k) clearance for the SHARPSMART DISPOSABLE SHARPS CONTAINER, MODEL S2. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Daniels Corporation Pty, Inc. (Virginia Beach, US). The FDA issued a Cleared decision on October 30, 2009 after a review of 141 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 - K091736

510(k) Number K091736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2009
Decision Date October 30, 2009
Days to Decision 141 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
12d slower than avg
Panel avg: 129d · This submission: 141d
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 104
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K091736.
BD RECYKLEEN SHARPS COLLECTORS
K112774 · Becton, Dickinson and Company · Mar 2012
SHARPS CONTAINER
K110262 · Noble Marketing · Apr 2011
SHARPS CONTAINER
K101567 · Cixi Leinuo Plastic Co., Ltd. · Sep 2010
SHARP CHUTE
K091690 · Heathrow Scientific, LLC · Jul 2009
ISOLYSER HOME SHARPS MANAGEMENT (HSM), MODEL 800M
K090157 · Wcm Waste & Compliance Management, Inc. · May 2009
ENVIRO SHARP SOLUTIONS 3
K083511 · Industrial Water Solutions, Inc. · Mar 2009
K091736 · SHARPSMART DISPOSABLE SHARPS CONTAINER, MODEL S2
Download PDF FDA Summary Daniels Corporation P…