# K121461: Bact/Alert FA Plus Culture Bottle

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Jan 22, 2013 after 250 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: 2 generations back to K992400 (1999). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020813: Bact/Alert FA Culture Bottle, bioMerieux, Inc. (2002) Summary page 2.

## Most influential descendants
- K183166: BacT/ALERT FA Plus; BacT/ALERT PF Plus (2019), 0 descendants of its own

## Indications for use
BacT/ALERT® FA Plus Culture Bottles are used with the BacT/ALERT® Microbial Detection System in qualitative procedures for recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood and other normally sterile body fluids.

Source page: https://510kreport.com/device/K121461
Methodology: https://510kreport.com/methodology