Cleared Special

K121283 - BD EMERALD SAF-T SINGLE USE, HYPODERMIC (FDA 510(k) Clearance)

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

K121283 · Becton, Dickinson and Company · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
30d
Days
Class 2
Risk

K121283 is an FDA 510(k) clearance for the BD EMERALD SAF-T SINGLE USE, HYPODERMIC. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on May 30, 2012 after a review of 30 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 and Company devices

Submission Details

510(k) Number K121283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2012
Decision Date May 30, 2012
Days to Decision 30 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
98d faster than avg
Panel avg: 128d · This submission: 30d
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 748
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