# K964560: Bhi W/Vancomycin Agar

- Pathway: 510(k) (Traditional)
- Applicant: Hardy Diagnostics
- Decided: Jan 15, 1997 after 63 days
- Product code: JSO (Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar)
- Device class: 2
- Regulation: 21 CFR 866.1700
- Recalls of this device: 2 (0 Class I)
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K020576: Velogene Genomic Identificationassay for Vre (2002), 0 descendants of its own

## Recalls of this device
- Dec 21, 2020 · Class II · Z-0919-2021: Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.
- Jun 27, 2006 · Not classified · Z-1451-06: This recall is being conducted due to the performance failure nearing the end of the product shelf life.

Source page: https://510kreport.com/device/K964560
Methodology: https://510kreport.com/methodology