# K193504: HardyDisk AST Cefiderocol 30ug (FDC30)

- Pathway: 510(k) (Traditional)
- Applicant: Hardy Diagnostics
- Decided: Jan 23, 2020 after 36 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K221826: BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) (2022), 0 descendants of its own

Source page: https://510kreport.com/device/K193504
Methodology: https://510kreport.com/methodology