Cleared Traditional

K233986 - BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233986 · Becton, Dickinson and Company · Microbiology device
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Mar 2024
Decision
88d
Days
Class 2
Risk

K233986 is an FDA 510(k) clearance for the BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL). Classified as System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (product code LON), Class II - Special Controls.

Submitted by Becton, Dickinson and Company (Sparks, US). The FDA issued a Cleared decision on March 15, 2024 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1645 - 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 Becton, Dickinson and Company devices

Submission Details

510(k) Number K233986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2023
Decision Date March 15, 2024
Days to Decision 88 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 102d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

Device Classification

Product Code LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1645
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 Microbiology devices follow this clearance model.

Regulatory Peers - LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

All 288
Devices cleared under the same product code (LON) and FDA review panel - the closest regulatory comparables to K233986.
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