# K021123: Bact/Alert SN Culture Bottle

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Apr 26, 2002 after 18 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
Longest line of descent: 1 generation back to K993421 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993421: Bact/Alert SN, Organon Teknika Corp. (1999) Summary page 2.

## Recalls of this device
- Aug 17, 2006 · Not classified · Z-0243-2007: Recovery Compromised-during manufacturing ambient air (including oxygen) was inadvertently introduced into the culture bottles, changing their reduction/oxidation potential thus leading to a compromis

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

Source page: https://510kreport.com/device/K021123
Methodology: https://510kreport.com/methodology