# K921133: Bactec Plus Aerobic/F and Anaerobic/F Media

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Apr 22, 1992 after 43 days
- Product code: MDB (System, Blood Culturing)
- Device class: 1
- Regulation: 21 CFR 866.2560
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K113558: BD BACTEC Plus Aerobic/F Culture Vials (plastic) (2012), 1 descendant of its own
- K083572: BD BACTEC Plus Aerobic/F Culture Vials (2008), 1 descendant of its own
- K222591: BD BACTEC™ Plus Aerobic/F Culture Vials (2023), 0 descendants of its own
- K120994: BD BACTEC Plus PRIME Aerobic/F Culture Vials (2012), 0 descendants of its own

## Recalls of this device
- Nov 11, 2009 · Not classified · Z-1008-2010: The draw volume on test tubes of blood culture medium is marked with graduations that may be confusing for healthcare practitioners using the tubes for appropriate collection of patient samples for mi
- Nov 11, 2009 · Not classified · Z-1009-2010: The draw volume on test tubes of blood culture medium is marked with graduations that may be confusing for healthcare practitioners using the tubes for appropriate collection of patient samples for mi
- Nov 11, 2009 · Not classified · Z-1010-2010: The draw volume on test tubes of blood culture medium is marked with graduations that may be confusing for healthcare practitioners using the tubes for appropriate collection of patient samples for mi
- Nov 11, 2009 · Not classified · Z-1011-2010: The draw volume on test tubes of blood culture medium is marked with graduations that may be confusing for healthcare practitioners using the tubes for appropriate collection of patient samples for mi

Source page: https://510kreport.com/device/K921133
Methodology: https://510kreport.com/methodology