# K230651: BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Jun 7, 2023 after 90 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 K192326 (2019). 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)
- K192326: HardyDisk AST Lefamulin 20µg (LMU20), Hardy Diagnostics (2019) Summary page 6.

## 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 Lefamulin Disc 20 μg (LMU-20) can be used to determine susceptibility to Lefamulin against the following bacteria, as described in the FDA-approved package insert for this antimicrobial agent. Active in vitro and in Clinical Infections Against: Gram-positive Bacteria Streptococcus pneumoniae Staphylococcus aureus (methicillin-susceptible isolates) Gram-negative Bacteria Haemophilus influenzae

Source page: https://510kreport.com/device/K230651
Methodology: https://510kreport.com/methodology