# K994343: Bact/Alert SV

- Pathway: 510(k) (Traditional)
- Applicant: Organon Teknika Corp.
- Decided: Feb 10, 2000 after 49 days
- Product code: MDB (System, Blood Culturing)
- Device class: 1
- Regulation: 21 CFR 866.2560
- Recalls of this device: none
- 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. The FDA summary names its predicate without a number.
- (no number) BacT/Alert Standard Aerobic Culture Bottle: named in the summary without a submission number

## Indications for use
The BacT/ALERT SV Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.

Source page: https://510kreport.com/device/K994343
Methodology: https://510kreport.com/methodology