# K973305: Bact/Alert Culture Bottles

- Pathway: 510(k) (Traditional)
- Applicant: Organon Teknika Corp.
- Decided: Nov 17, 1997 after 75 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
Longest line of descent: 1 generation back to K903505 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903505: Bact/Alert (TM), Organon Teknika Corp. (1991) Summary page 2.

## Indications for use
BacT/Alert Culture Bottles are used with the BacT/Alert Microbial Detection System in qualitative procedures for recovery and detection of aerobic and anaerobic microorganisms from blood and other body fluids.

Source page: https://510kreport.com/device/K973305
Methodology: https://510kreport.com/methodology