# K951539: Enterococcus Screening Medium

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Microbiology Systems
- Decided: Jun 13, 1995 after 71 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: 4 (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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jun 29, 2015 · Class II · Z-0474-2016: The affected expired lots of product may have exhibited breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life. The in-date product may also exhibit 
- Jun 29, 2015 · Class II · Z-0473-2016: The affected expired lots of product may have exhibited breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life. The in-date product may also exhibit 
- Jul 28, 2014 · Class II · Z-2628-2014: These lots of Agar may have exhibited breakthrough growth of vancomycin susceptible Enterococcus species control organisms. Agar that allows susceptible enterococci to grow appears as a falsely resist
- Jun 6, 2013 · Class II · Z-1798-2013: Microbiological identification media may exhibit reduced levels of Vancomycin.

Source page: https://510kreport.com/device/K951539
Methodology: https://510kreport.com/methodology