# K172621: HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)

- Pathway: 510(k) (Traditional)
- Applicant: Hardy Diagnostics
- Decided: Oct 3, 2017 after 33 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
- K181975: Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 (2018), 0 descendants of its own

## Indications for use
Use of HardyDisk™ Meropenem/Vaborbactam 20/10ug (MEV30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of bacteria to Meropenem/Vaborbactam. Meropenem/Vaborbactam has been shown to be active against susceptible isolates of the following microorganisms both in vitro and in clinical infections: Enterobacter cloacae species complex Escherichia coli Klebsiella pneumoniae Meropenem/Vaborbactam has been shown to be active in vifro against susceptible isolates of the following microorganisms: Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Klebsiella oxytoca Morganella morganii Proteus mirabilis Providencia spp. Pseudomonas aeruginosa Serratia marcescens. HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Strepfococcus spp., including Strepfococcus pneumoniae.

Source page: https://510kreport.com/device/K172621
Methodology: https://510kreport.com/methodology