510(k) · Cleared
Recalled · Class II · 2023BD BACTEC Plus Aerobic/F Culture Vials (plastic)
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 Mar 16, 2012 as substantially equivalent to K921133 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1992) after a 106-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it. It has been recalled once.
- Decided
- Mar 16, 2012
- Review
- 106 days
- Class
- Class I
- Product code
- MDB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K921133 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK921133 Bactec Plus Aerobic/F and Anaerobic/F MediaBd Becton Dickinson Vacutainer Systems Preanalytic · 1992 · Recalled
- This deviceK113558 BD BACTEC Plus Aerobic/F Culture Vials (plastic)Becton, Dickinson and Company · 2012
- Descendant · cites it directly · 0 of its ownK222591 BD BACTEC™ Plus Aerobic/F Culture VialsBecton, Dickinson and Company · 2023
Most influential descendants
Showing 1 of 1 · See all- K222591BD BACTEC™ Plus Aerobic/F Culture VialsBecton, Dickinson and Company · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921133 | Bactec Plus Aerobic/F and Anaerobic/F Media | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992 | 4 |
| 0 (this device) | K113558 | BD BACTEC Plus Aerobic/F Culture Vials (plastic) | Becton, Dickinson and Company | 2012 | — |
| +1 | K222591 | BD BACTEC™ Plus Aerobic/F Culture Vials | Becton, Dickinson and Company | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
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 |
|---|---|---|---|
| * | K921133 | Bactec Plus Aerobic/F and Anaerobic/F MediaSummary page 1…od culture medium DEVICE CLASSIFICATION: 21 CFR§866.2560, Class I PREDICATE DEVICE: BD BACTEC PLUS Aerobic/F medium (K921 133) INTENDED USE: The BD BACTEC Plus Aerobic/F medium is used in a qualitative procedure for the aerobic culture and recovery of mi… | 1992 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222591 | BD BACTEC™ Plus Aerobic/F Culture Vials | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 12, 2023 | Class II | Z-0110-2024 | Under Investigation by firm | Certain vials of the BD BACTEC" Plus Aerobic/F Culture Vials have a labeling issue where duplicate barcode sequence numbers have been identified on more than one vial. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 Aerobic/F medium is used in a qualitative procedure for the aerobic culture and recovery of microorganisms (bacteria and yeast) from blood. The principal use of this medium is with the BD BACTEC fluorescent series instruments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113558 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113558: BD BACTEC Plus Aerobic/F Culture Vials (plastic).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113558
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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