Cleared Special

BD EMERALD SINGLE USE, HYPODERMIC SYRINGE (K113241) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K113241 · Becton Dickinson · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
26d
Days
Class 2
Risk

K113241 is an FDA 510(k) clearance for the BD EMERALD SINGLE USE, HYPODERMIC SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Becton Dickinson (Franklin Lakes, US). The FDA issued a Cleared decision on November 28, 2011 after a review of 26 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Becton Dickinson devices

Submission Details

510(k) Number K113241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2011
Decision Date November 28, 2011
Days to Decision 26 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 129d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 242
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K113241.
PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM
K141762 · Biomet, Inc. · Aug 2014
BD EMERALD SAF-T SINGLE USE, HYPODERMIC
K121283 · Becton, Dickinson and Company · May 2012
ARTHREX MIXING AND DELIVERY SYSTEM
K121124 · Arthrex, Inc. · May 2012
MERIT MEDICAL 20 ML SYRINGE
K111091 · Merit Medical Systems, Inc. · Jun 2011
BD SINGLE USE, HYPODERMIC SYRINGE
K110771 · Becton, Dickinson and Company · May 2011
COAXIAL APPLICATOR SYSTEM
K091722 · Biomet, Inc. · Mar 2010