# K020815: Bact/Alert FN Culture Bottle

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Apr 18, 2002 after 36 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 K992432 (1999). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992432: Bact/Alert FN, Organon Teknika Corp. (1999) Summary page 2.

## Most influential descendants
- K121455: Bact/Alert FN Plus Culture Bottle (2013), 0 descendants of its own

## Indications for use
BacT/ALERT®FN Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of anaerobic microorganisms from blood, and other normally sterile body fluids.

Source page: https://510kreport.com/device/K020815
Methodology: https://510kreport.com/methodology