Cleared Traditional

K970737 - B-D ULTRA-FINE II SHORT 31G X 5/16 PEN ...

K970737 is the FDA 510(k) clearance for B-D ULTRA-FINE II SHORT 31G X 5/16 PEN ... by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 General Hospital device (product code FMI) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K970737 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
28d
Days
Class 2
Risk

K970737 is an FDA 510(k) clearance for the B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lake, US). The FDA issued a Cleared decision on March 28, 1997 after a review of 28 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K970737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1997
Decision Date March 28, 1997
Days to Decision 28 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
101d faster than avg
Panel avg: 129d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 260
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K970737.
SHARPS SHUTTLE
K972279 · Sage Products, Inc. · Aug 1997
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
LIFESHIELD BLUNT CANNULA
K963351 · Abbott Laboratories · Feb 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