# K993421: Bact/Alert SN

- Pathway: 510(k) (Traditional)
- Applicant: Organon Teknika Corp.
- Decided: Dec 14, 1999 after 63 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.
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 Anaerobic Culture Bottle: named in the summary without a submission number

## Most influential descendants
- K021123: Bact/Alert SN Culture Bottle (2002), 0 descendants of its own

## Recalls of this device
- Dec 24, 2015 · Class II · Z-0749-2016: Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.

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

Source page: https://510kreport.com/device/K993421
Methodology: https://510kreport.com/methodology