Cleared Traditional

K023219 - BECTON DICKINSON DIABETES SOFTWARE

K023219 is an FDA 510(k) clearance for BECTON DICKINSON DIABETES SOFTWARE, manufactured by Becton, Dickinson & CO. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K023219 · Becton, Dickinson & CO · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
71d
Days
Class 2
Risk

K023219 is an FDA 510(k) clearance for the BECTON DICKINSON DIABETES SOFTWARE. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Becton, Dickinson & CO (Franklin Lakes, US). The FDA issued a Cleared decision on December 6, 2002 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry 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 Becton, Dickinson & CO devices

FDA 510(k) Submission Details - K023219

510(k) Number K023219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2002
Decision Date December 06, 2002
Days to Decision 71 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 88d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NBW Device Classification - Class 2, Special Controls

Product Code NBW System, Test, Blood Glucose, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 Chemistry devices follow this clearance model.

Regulatory Peers - NBW System, Test, Blood Glucose, Over The Counter

All 266
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K023219.
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K022724 · Lifescan, Inc. · Sep 2002