# K992401: Bact/Alert PF

- 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 Pedi-BacT Culture Bottle: named in the summary without a submission number

## Most influential descendants
- K020923: Bact/Alert PF Culture Bottle (2002), 2 descendants of its own
- K121446: Bact/Alert PF 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 PF 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 yeast) from blood.

Source page: https://510kreport.com/device/K992401
Methodology: https://510kreport.com/methodology