# K221826: BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Dec 21, 2022 after 181 days
- Product code: JTN (Susceptibility Test Discs, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 866.1620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K193504 (2020). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193504: HardyDisk AST Cefiderocol 30ug (FDC30), Hardy Diagnostics (2020) Summary page 7.

## Indications for use
Intended Use/Indications for Use: BD BBL Sensi-Disc Antimicrobial Susceptibility Test (AST) Discs are used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing. BD BBL Sensi-Disc Cefiderocol Disc 30 µg (FDC-30) can be used to determine susceptibility to Cefiderocol against the following bacteria, as described in the FDA-approved package insert for this antimicrobial agent. Active in vitro and in Clinical Infections Against: Complicated Urinary Tract Infections, Including Pyelonephritis Gram-negative Bacteria Escherichia coli Enterobacter cloacae complex Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP) Gram-negative Bacteria Acinetobacter baumannii complex Escherichia coli Enterobacter cloacae complex Klebsiella pneumoniae Pseudomonas aeruginosa Serratia marcescens Active in vitro Against: Citrobacter freundii complex Citrobacter koseri Klebsiella aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia rettgeri

Source page: https://510kreport.com/device/K221826
Methodology: https://510kreport.com/methodology