Cleared Special

K250344 - BD Phoenix™ Automated Microbiology System (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K250344 · Becton, Dickinson and Company · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
28d
Days
Class 2
Risk

K250344 is an FDA 510(k) clearance for the BD Phoenix™ Automated Microbiology System. 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 6, 2025 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Becton, Dickinson and Company devices

Submission Details

510(k) Number K250344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2025
Decision Date March 06, 2025
Days to Decision 28 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 102d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K250344.
VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance
K260282 · bioMerieux, Inc. · Apr 2026
VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)
K260281 · BIOMERIEUX · Mar 2026
VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)
K251579 · bioMerieux, Inc. · Aug 2025
BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)
K251713 · Becton, Dickinson and Company · Aug 2025
BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)
K250447 · Becton, Dickinson and Company · May 2025
VITEK COMPACT PRO
K234012 · bioMerieux, Inc. · Mar 2025