Cleared Special

BD SINGLE USE, HYPODERMIC SYRINGE (K110771) - FDA 510(k) Clearance

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

K110771 · Becton, Dickinson and Company · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
53d
Days
Class 2
Risk

K110771 is an FDA 510(k) clearance for the BD SINGLE USE, HYPODERMIC SYRINGE. 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 13, 2011 after a review of 53 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 K110771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2011
Decision Date May 13, 2011
Days to Decision 53 days
Submission Type Special
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
76d faster than avg
Panel avg: 129d · This submission: 53d
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 239
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