510(k) · Cleared
ClearedBacT/ALERT FA Plus; BacT/ALERT PF Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
bioMerieux, Inc. · MDB System, Blood Culturing
Cleared on Feb 11, 2019 as substantially equivalent to K121461 (bioMerieux, Inc., 2013) and 1 other predicate after an 88-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Feb 11, 2019
- Review
- 88 days
- Class
- Class I
- Product code
- MDB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K992400 (1999). 6 ancestors in all, the oldest K992401 (1999). No later device cites it as a predicate yet.
- Root · 3 generations backK992400 Bactalert FAOrganon Teknika Corp. · 1999
- 2 generations backK020813 Bact/Alert FA Culture BottlebioMerieux, Inc. · 2002 · Recalled
- 1 generation backK121461 Bact/Alert FA Plus Culture BottlebioMerieux, Inc. · 2013
- This deviceK183166 BacT/ALERT FA Plus; BacT/ALERT PF PlusbioMerieux, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K992400 | Bactalert FA | Organon Teknika Corp. | 1999 | — |
| −2 | K020813 | Bact/Alert FA Culture Bottle | bioMerieux, Inc. | 2002 | 3 |
| −1 | K121461 | Bact/Alert FA Plus Culture Bottle | bioMerieux, Inc. | 2013 | — |
| 0 (this device) | K183166 | BacT/ALERT FA Plus; BacT/ALERT PF Plus | bioMerieux, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2013 | 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? (2)
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 |
|---|---|---|---|
| * | K121461 | Bact/Alert FA Plus Culture BottleSummary page 4…BacT/ALERT® FA Plus BacT/ALERT® PF Plus C. Predicate Device: BacT/ALERT® FA Plus (k121461) BacT/ALERT® PF Plus (k121446) D. 510(k) Summary: Principle of the Test… | 2013 |
| * | K121446 | Bact/Alert PF Plus Culture BottleSummary page 4…BacT/ALERT® PF Plus C. Predicate Device: BacT/ALERT® FA Plus (k121461) BacT/ALERT® PF Plus (k121446) D. 510(k) Summary: Principle of the Test The BacT/ALERT® Microbial Detection Systems utilizes a colorimetric senso… | 2013 |
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 2 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 6 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. 2019, 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?
BacT/ALERT® FA Plus Culture Bottles are used with BacT/ALERT® Microbial Detection Systems in qualitative procedures for recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood and other normally sterile body fluids.
BacT/ALERT® PF Plus Culture Bottles are used with BacT/ALERT® Microbial Detection Systems in qualitative procedures for recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183166 · printed Nov 3, 2026
Cite this page
510(k) Report. “K183166: BacT/ALERT FA Plus; BacT/ALERT PF Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K183166
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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