# K193538: Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Fisher Scientific
- Decided: Mar 12, 2020 after 83 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Jan 10, 2022 · Class II · Z-0722-2022: There are lower than expected MICs for some gram negative species.

Source page: https://510kreport.com/device/K193538
Methodology: https://510kreport.com/methodology