# K915796: Bactec 9240 System

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Apr 22, 1992 after 120 days
- Product code: MDB (System, Blood Culturing)
- Device class: 1
- Regulation: 21 CFR 866.2560
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K172412: BacterioScan 216Dx System (2018), 0 descendants of its own
- K161306: BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial (2016), 0 descendants of its own

## Recalls of this device
- Sep 23, 2025 · Class II · Z-0236-2026: Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is 
- Oct 31, 2024 · Class II · Z-0594-2025: BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are 
- Oct 31, 2024 · Class II · Z-0593-2025: BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are 
- Oct 31, 2024 · Class II · Z-0596-2025: BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are 
- Dec 9, 2013 · Class II · Z-0869-2014: Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens.
- Dec 9, 2013 · Class II · Z-0870-2014: Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens.

Source page: https://510kreport.com/device/K915796
Methodology: https://510kreport.com/methodology