# K183031: ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)

- Pathway: 510(k) (Traditional)
- Applicant: Biomerieux S.A.
- Decided: Jan 11, 2019 after 71 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K250274: ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) (2025), 0 descendants of its own
- K232395: ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST®  SUD (2023), 0 descendants of its own
- K191953: ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) (2019), 0 descendants of its own

Source page: https://510kreport.com/device/K183031
Methodology: https://510kreport.com/methodology