510(k) · Cleared
ClearedBD BACTEC Plus PRIME Aerobic/F Culture Vials
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · MDB System, Blood Culturing
Cleared on Aug 7, 2012 as substantially equivalent to K083572 (Becton, Dickinson & CO, 2008) after a 127-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Aug 7, 2012
- Review
- 127 days
- Class
- Class I
- Product code
- MDB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K921133 (1992). No later device cites it as a predicate yet.
- Root · 2 generations backK921133 Bactec Plus Aerobic/F and Anaerobic/F MediaBd Becton Dickinson Vacutainer Systems Preanalytic · 1992 · Recalled
- 1 generation backK083572 BD BACTEC Plus Aerobic/F Culture VialsBecton, Dickinson & CO · 2008
- This deviceK120994 BD BACTEC Plus PRIME Aerobic/F Culture VialsBecton, Dickinson and Company · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921133 | Bactec Plus Aerobic/F and Anaerobic/F Media | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992 | 4 |
| −1 | K083572 | BD BACTEC Plus Aerobic/F Culture Vials | Becton, Dickinson & CO | 2008 | — |
| 0 (this device) | K120994 | BD BACTEC Plus PRIME Aerobic/F Culture Vials | Becton, Dickinson and Company | 2012 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MDB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MDB device
- #1 K260213 BD BACTEC FXI Culture Systemscore 11.4 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083572 | BD BACTEC Plus Aerobic/F Culture VialsSummary page 1…od culture medium DEVICE CLASSIFICATION: 21 CFR§866.2560, Class I PREDICATE DEVICE: BD BACTEC PLUS Aerobic/F medium (K083572) INTENDED USE: The BD BACTEC Plus PRME Aerobic/F medium is used in a qualitative procedure for the aerobic culture and recovery… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 16.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All MDB devicesMDB System, Blood Culturing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MDB
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MDB
252in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MDB
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MDB
1,977in 2025
MAUDE reports naming product code MDB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 2 | 1 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 0 | — | 4 | 1 |
| 2010 | 0 | — | 2 | 1 |
| 2011 | 0 | — | 2 | 6 |
| 2012 | 2 | — | 33 | 4 |
| 2013 | 4 | 252 | 3 | 5 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 2 | 12 |
| 2016 | 2 | — | 0 | 291 |
| 2017 | 2 | — | 0 | 121 |
| 2018 | 1 | — | 3 | 76 |
| 2019 | 2 | — | 0 | 147 |
| 2020 | 0 | — | 0 | 37 |
| 2021 | 0 | — | 0 | 1,184 |
| 2022 | 0 | — | 0 | 643 |
| 2023 | 2 | — | 1 | 1,232 |
| 2024 | 0 | — | 4 | 401 |
| 2025 | 0 | — | 2 | 1,977 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The BD BACTEC Plus PRIME Aerobic/F blood culture medium is used in a qualitative procedure for the aerobic culture and recovery of microorganisms (bacteria and yeast) from blood. The principle use of this medium is with BD BACTEC Fluorescent Series Instruments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120994 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120994: BD BACTEC Plus PRIME Aerobic/F Culture Vials.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120994
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026