# K790366: Urine Culture Kit

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Apr 4, 1979 after 41 days
- Product code: JTW (System, Transport, Aerobic)
- Device class: 1
- Regulation: 21 CFR 866.2900
- 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.
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
- Aug 30, 2018 · Class II · Z-0491-2019: BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good Clinical Practice (G
- Oct 12, 2009 · Not classified · Z-1026-2010: A small amount of discoloration was noted on Towelettes included in BD Vacutainer Urine collection kits. The entire kit components retain sterile interiors and no viable growth was detected on the tow

Source page: https://510kreport.com/device/K790366
Methodology: https://510kreport.com/methodology