# K992432: Bact/Alert FN

- Pathway: 510(k) (Traditional)
- Applicant: Organon Teknika Corp.
- Decided: Sep 24, 1999 after 65 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
No predicates in its family tree.
2 later devices descend 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)
- None. The FDA summary names its predicate without a number.
- (no number) BacT/Alert FAN Anaerobic Culture Bottle: named in the summary without a submission number

## Most influential descendants
- K020815: Bact/Alert FN Culture Bottle (2002), 1 descendant of its own
- K121455: Bact/Alert FN Plus Culture Bottle (2013), 0 descendants of its own

## Recalls of this device
- Feb 16, 2007 · Not classified · Z-1189-2007: Microbial Contamination: Bacillus sp. contamination was detected in inoculated bottles.

## Indications for use
The 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/K992432
Methodology: https://510kreport.com/methodology