Cleared Traditional

K132476 - SHARPS CONTAINER

K132476 is an FDA 510(k) clearance for SHARPS CONTAINER, manufactured by Grp & Associates. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K132476 · Grp & Associates · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
267d
Days
Class 2
Risk

K132476 is an FDA 510(k) clearance for the SHARPS CONTAINER. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Grp & Associates (Austin, US). The FDA issued a Cleared decision on May 2, 2014 after a review of 267 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 - K132476

510(k) Number K132476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2013
Decision Date May 02, 2014
Days to Decision 267 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
138d slower than avg
Panel avg: 129d · This submission: 267d
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 K132476.
MedSource Sharps Dart
K150333 · Medsource International, LLC · May 2015
B TRAVELSAVVY SHARPS CONTAINER
K140285 · Bellegrove Medical Supply, Inc. · Dec 2014
OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERS
K141759 · Oak Ridge Products, LLC · Oct 2014
BWCSH-1 SHARPS CONTAINER
K131708 · Bradford Wright Companies, Inc. · Mar 2014
MEDLINE SHARPS CONTAINER
K132767 · Medline Industries, Inc. · Feb 2014
ECOSHIP DISPOSABLE SHARPS CONTAINER, ECOSHIP DISPOSABLE SHARPS CONTAINER
K132792 · Daniels Sharpsmart, Inc. · Jan 2014
K132476 · SHARPS CONTAINER
Download PDF FDA Summary Grp & Associates