Cleared Traditional

K112774 - BD RECYKLEEN SHARPS COLLECTORS

K112774 is an FDA 510(k) clearance for BD RECYKLEEN SHARPS COLLECTORS, manufactured by Becton, Dickinson and Company. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K112774 · Becton, Dickinson and Company · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
187d
Days
Class 2
Risk

K112774 is an FDA 510(k) clearance for the BD RECYKLEEN SHARPS COLLECTORS. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on March 28, 2012 after a review of 187 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.

View all Becton, Dickinson and Company devices

FDA 510(k) Submission Details - K112774

510(k) Number K112774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2011
Decision Date March 28, 2012
Days to Decision 187 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
58d slower than avg
Panel avg: 129d · This submission: 187d
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 39
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K112774.
HealthBeacon HB2 Sharps Bin
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MEDLINE SHARPS CONTAINERS
K143693 · Medline Industries, Inc. · Nov 2015
MEDLINE SHARPS CONTAINER
K132767 · Medline Industries, Inc. · Feb 2014
SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS
K980490 · Sage Products, Inc. · Feb 1998
POINT OF USE II SHARPS-A-GATOR
K964387 · Graphic Controls Corp. · Mar 1997
CHEMOTHERAPY WASTE DISPOSAL CONTAINERS
K943658 · Sage Products, Inc. · Mar 1995