Atlas FDA

BD Phoenix™ Automated Microbiology System

FDA 510(k) clearance K250344 · decided 2025-03-06

Clearance details

K-number
K250344
Device name
BD Phoenix™ Automated Microbiology System
Applicant
Becton, Dickinson and Company
Decision
Substantially Equivalent
Date received
2025-02-06
Decision date
2025-03-06
Days to decision
28 days
Clearance type
Special
Product code
LON
Device class
2
Regulation number
866.1645
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Sparks, MD, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance (K260282)bioMerieux, Inc.2026-04-15
VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) (K260281)BIOMERIEUX2026-03-26
VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (K251579)bioMerieux, Inc.2025-08-21
BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) (K251713)Becton, Dickinson and Company2025-08-08
BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) (K250447)Becton, Dickinson and Company2025-05-19
VITEK COMPACT PRO (K234012)bioMerieux, Inc.2025-03-14
BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) (K233986)Becton, Dickinson and Company2024-03-15
VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) (K234000)bioMerieux, Inc.2024-03-11
Colibrí (K232756)Copan Wasp Srl2023-12-27
VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin (K232201)bioMerieux, Inc.2023-10-23
VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (K230864)bioMerieux, Inc.2023-07-05
VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL) (K222378)bioMerieux, Inc.2023-06-26

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
BD ONCLARITY HPV ASSAY (P160037/S022)Becton, Dickinson and Company2025-08-25
BD Onclarity HPV Assay (P160037/S023)Becton, Dickinson and Company2025-07-02
Onclarity HPV Assay (P160037/S021)Becton, Dickinson and Company2025-03-12
BD Onclarity™ HPV Assay (P160037/S020)Becton, Dickinson and Company2024-11-05
BD Onclarity HPV Assay (P160037/S017)Becton, Dickinson and Company2024-05-14
BD Onclarity™ HPV Assay (P160037/S019)Becton, Dickinson and Company2024-04-18
BD Onclarity HPV Assay (P160037/S018)Becton, Dickinson and Company2023-11-20
BD Onclarity HPV (P160037/S016)Becton, Dickinson and Company2023-11-15