510(k) · Cleared
Recalled · 2009Bactec Plus Aerobic/F and Anaerobic/F Media
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Becton Dickinson Vacutainer Systems Preanalytic · MDB System, Blood Culturing
Cleared on Apr 22, 1992 after a 43-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it. It has been recalled 4 times.
- Decided
- Apr 22, 1992
- Review
- 43 days
- Class
- Class I
- Product code
- MDB
- Recalls
- 4
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK921133 Bactec Plus Aerobic/F and Anaerobic/F MediaBd Becton Dickinson Vacutainer Systems Preanalytic · 1992
- Descendant · cites it directly · 1 of its ownK113558 BD BACTEC Plus Aerobic/F Culture Vials (plastic)Becton, Dickinson and Company · 2012 · Recalled
- Descendant · cites it directly · 1 of its ownK083572 BD BACTEC Plus Aerobic/F Culture VialsBecton, Dickinson & CO · 2008
- Descendant · 2 generations on · 0 of its ownK222591 BD BACTEC™ Plus Aerobic/F Culture VialsBecton, Dickinson and Company · 2023
- Descendant · 2 generations on · 0 of its ownK120994 BD BACTEC Plus PRIME Aerobic/F Culture VialsBecton, Dickinson and Company · 2012
Most influential descendants
Showing 4 of 4 · See all- K113558BD BACTEC Plus Aerobic/F Culture Vials (plastic)Becton, Dickinson and Company · 2012 · cites it directly1descendant
- K083572BD BACTEC Plus Aerobic/F Culture VialsBecton, Dickinson & CO · 2008 · cites it directly1descendant
- K222591BD BACTEC™ Plus Aerobic/F Culture VialsBecton, Dickinson and Company · 2023 · 2 generations on0descendants
- K120994BD BACTEC Plus PRIME Aerobic/F Culture VialsBecton, Dickinson and Company · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K921133 | Bactec Plus Aerobic/F and Anaerobic/F Media | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992 | — |
| +1 | K113558 | BD BACTEC Plus Aerobic/F Culture Vials (plastic) | Becton, Dickinson and Company | 2012 | 1 |
| +1 | K083572 | BD BACTEC Plus Aerobic/F Culture Vials | Becton, Dickinson & CO | 2008 | — |
| +2 | K222591 | BD BACTEC™ Plus Aerobic/F Culture Vials | Becton, Dickinson and Company | 2023 | — |
| +2 | K120994 | BD BACTEC Plus PRIME Aerobic/F Culture Vials | Becton, Dickinson and Company | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 2 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 11, 2009 | Not classified | Z-1008-2010 | Component change control | 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 microbiological laboratory testing. |
| Nov 11, 2009 | Not classified | Z-1009-2010 | Component change control | 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 microbiological laboratory testing. |
| Nov 11, 2009 | Not classified | Z-1010-2010 | Component change control | 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 microbiological laboratory testing. |
| Nov 11, 2009 | Not classified | Z-1011-2010 | Component change control | 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 microbiological laboratory testing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K113558 (Becton, Dickinson and Company, 2012) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MDB devicesMDB System, Blood Culturing: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K921133 · printed Nov 4, 2026
Cite this page
510(k) Report. “K921133: Bactec Plus Aerobic/F and Anaerobic/F Media.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K921133
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026