Cleared Traditional

K964654 - BECTON DICKINSON BLUNT PLASTIC CANNULA

K964654 is an FDA 510(k) clearance for BECTON DICKINSON BLUNT PLASTIC CANNULA, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K964654 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
133d
Days
Class 2
Risk

K964654 is an FDA 510(k) clearance for the BECTON DICKINSON BLUNT PLASTIC CANNULA. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on April 2, 1997 after a review of 133 days - within the typical 510(k) review window.

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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K964654

510(k) Number K964654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1996
Decision Date April 02, 1997
Days to Decision 133 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
4d slower than avg
Panel avg: 129d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
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 - FMI Needle, Hypodermic, Single Lumen

All 494
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K964654.
VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR
K963571 · Vygon Corp. · Jun 1997
F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM
K970380 · Pyng Medical Corp. · Apr 1997
TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE
K970370 · Tsk Laboratory, Japan · Apr 1997
B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE
K970737 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1997
LIFESHIELD BLUNT CANNULA
K963351 · Abbott Laboratories · Feb 1997
BEMIS TWO GALLON SHARPS CONTAINER
K965248 · Bemis Mfg. Co. · Feb 1997