# K983772: MB/Bact Blood Culture Bottle

- Pathway: 510(k) (Traditional)
- Applicant: Organon Teknika Corp.
- Decided: Jan 13, 1999 after 79 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
Longest line of descent: 1 generation back to K863191 (1986). 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)
- K863191: Bactec 13A Medium (7H13), Bd Becton Dickinson Vacutainer Systems Preanalytic (1986) Summary page 2.

## Indications for use
MB/BacT Blood Culture Bottles in combination with the MB/BacT Enrichment Fluid are specifically designed for the cultivation of Mycobacterium sp. commonly isolated from blood when used in conjunction with the MB/BacT Mycobacterial Detection Systems (non-shaking detection systems) and the BacT/Alert Microbial Detection Systems (shaking detection systems).

Source page: https://510kreport.com/device/K983772
Methodology: https://510kreport.com/methodology