# K993423: Bact/Alert SA

- Pathway: 510(k) (Traditional)
- Applicant: Organon Teknika Corp.
- Decided: Dec 15, 1999 after 64 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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 Standard Aerobic Culture Bottle: named in the summary without a submission number

## Most influential descendants
- K020931: Bact/Alert SA Culture Bottle (2002), 0 descendants of its own

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

Source page: https://510kreport.com/device/K993423
Methodology: https://510kreport.com/methodology