Cleared Traditional

K963351 - LIFESHIELD BLUNT CANNULA

K963351 is an FDA 510(k) clearance for LIFESHIELD BLUNT CANNULA, manufactured by Abbott Laboratories. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K963351 · Abbott Laboratories · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
184d
Days
Class 2
Risk

K963351 is an FDA 510(k) clearance for the LIFESHIELD BLUNT CANNULA. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on February 26, 1997 after a review of 184 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K963351

510(k) Number K963351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1996
Decision Date February 26, 1997
Days to Decision 184 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 129d · This submission: 184d
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 271
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K963351.
VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR
K963571 · Vygon Corp. · Jun 1997
BECTON DICKINSON BLUNT PLASTIC CANNULA
K964654 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1997
B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE
K970737 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1997
MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE
K962001 · Manan Medical Products, Inc. · Jan 1997
MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA
K960982 · Sherwood Medical Co. · Dec 1996
NON-CORING NEEDLE
K961088 · Arrow Intl., Inc. · Jul 1996