Cleared Traditional

K865021 - BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM (FDA 510(k) Clearance)

Class I Microbiology device.

K865021 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Feb 1987
Decision
45d
Days
Class 1
Risk

K865021 is an FDA 510(k) clearance for the BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM. Classified as Monitor, Microbial Growth (product code JTA), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on February 6, 1987 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2560 - the FDA microbiology 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 K865021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1986
Decision Date February 06, 1987
Days to Decision 45 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 102d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTA Monitor, Microbial Growth
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2560
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.