# K181975: Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30

- Pathway: 510(k) (Traditional)
- Applicant: Oxoid Limited (Part of Thermo Fisher Scientific)
- Decided: Sep 27, 2018 after 65 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 K172621 (2017). 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)
- K172621: HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30), Hardy Diagnostics (2017) Summary page 5.

## Indications for use
Thermo Scientific™ Oxoid™Antimicrobial Susceptibility Test (AST) Discs are used in the semi quantitative agar diffusion test method for in vitro susceptibility testing. The Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV 30 can be used to determine susceptibility to Meropenem/Vaborbactam against the following bacteria for which Meropenem/Vaborbactam has been shown to be active both clinically and in vitro: Escherichia coli Klebsiella pneumoniae Enterobacter cloacae species complex

Source page: https://510kreport.com/device/K181975
Methodology: https://510kreport.com/methodology