# K020931: Bact/Alert SA Culture Bottle

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Apr 18, 2002 after 27 days
- Product code: MDB (System, Blood Culturing)
- Device class: 1
- Regulation: 21 CFR 866.2560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K993423 (1999). 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)
- K993423: Bact/Alert SA, Organon Teknika Corp. (1999) Summary page 2.

## Recalls of this device
- Dec 25, 2012 · Class II · Z-0738-2013: BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors.

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

Source page: https://510kreport.com/device/K020931
Methodology: https://510kreport.com/methodology