# K992400: Bactalert FA

- Pathway: 510(k) (Traditional)
- Applicant: Organon Teknika Corp.
- Decided: Sep 3, 1999 after 46 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
No predicates in its family tree.
3 later devices descend 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)
- None. The FDA summary names its predicate without a number.
- (no number) BacT/Alert FAN Aerobic Culture Bottle: named in the summary without a submission number

## Most influential descendants
- K020813: Bact/Alert FA Culture Bottle (2002), 2 descendants of its own
- K121461: Bact/Alert FA Plus Culture Bottle (2013), 1 descendant of its own
- K183166: BacT/ALERT FA Plus; BacT/ALERT PF Plus (2019), 0 descendants of its own

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

Source page: https://510kreport.com/device/K992400
Methodology: https://510kreport.com/methodology