# K953223: Piperacilin Tazobactam 4 UG

- Pathway: 510(k) (Traditional)
- Applicant: Ab Biodisk
- Decided: Aug 15, 1995 after 123 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: 4 (4 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.
1 of 1 device in its family (counting itself) has 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.

## Recalls of this device
- Nov 19, 2015 · Class I · Z-0439-2016: Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results.
- Nov 19, 2015 · Class I · Z-0442-2016: Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results.
- Nov 19, 2015 · Class I · Z-0440-2016: Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results.
- Nov 19, 2015 · Class I · Z-0441-2016: Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results.

Source page: https://510kreport.com/device/K953223
Methodology: https://510kreport.com/methodology