510(k) · Cleared
ClearedBD BACTEC FXI Culture System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BD Diagnostic Systems · MDB System, Blood Culturing
Cleared on May 28, 2026 as substantially equivalent to K962210 (Becton Dickinson Diagnostic Instrument Systems, 1996) after a 125-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- May 28, 2026
- Review
- 125 days
- Class
- Class I
- Product code
- MDB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962210 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK962210 Bactec 9050 SystemBecton Dickinson Diagnostic Instrument Systems · 1996
- This deviceK260213 BD BACTEC FXI Culture SystemBD Diagnostic Systems · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962210 | Bactec 9050 System | Becton Dickinson Diagnostic Instrument Systems | 1996 | — |
| 0 (this device) | K260213 | BD BACTEC FXI Culture System | BD Diagnostic Systems | 2026 | — |
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 K222591 BD BACTEC™ Plus Aerobic/F Culture Vialsscore 5.4 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K962210 | Bactec 9050 SystemSummary page 9…aboratory protocol. V. Substantial Equivalence 1 Information: Predicate Device Name: BD BACTEC™ 9050 System Predicate Device 510(k) Number: K962210 Comparison of the Predicate Device to the Candidate Device The similarities and differences of the predicat… | 1996 |
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?
- Its one ancestor has no recall.
How does its category compare?
All MDB devicesMDB System, Blood Culturing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 automated BD BACTEC FXI Culture System is designed for the qualitative detection of bacteria and fungi in blood.
Samples are collected from patients and injected directly into BD BACTEC culture vials, which are placed into the instrument for incubation and testing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260213: BD BACTEC FXI Culture System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260213
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026