510(k) · Cleared
Recalled · Class II · 2015Bact/Alert FA Culture Bottle
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 Apr 17, 2002 as substantially equivalent to K992400 (Organon Teknika Corp., 1999) after a 35-day review. Its family tree reaches back 1 generation to 1999. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Apr 17, 2002
- Review
- 35 days
- Class
- Class I
- Product code
- MDB
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992400 (1999). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK992400 Bactalert FAOrganon Teknika Corp. · 1999
- This deviceK020813 Bact/Alert FA Culture BottlebioMerieux, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK121461 Bact/Alert FA Plus Culture BottlebioMerieux, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK183166 BacT/ALERT FA Plus; BacT/ALERT PF PlusbioMerieux, Inc. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992400 | Bactalert FA | Organon Teknika Corp. | 1999 | — |
| 0 (this device) | K020813 | Bact/Alert FA Culture Bottle | bioMerieux, Inc. | 2002 | — |
| +1 | K121461 | Bact/Alert FA Plus Culture Bottle | bioMerieux, Inc. | 2013 | — |
| +2 | K183166 | BacT/ALERT FA Plus; BacT/ALERT PF Plus | bioMerieux, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K992400 | Bactalert FASummary page 2…/or differences with marketed device are listed in Table (a) (6) 1. TABLE (a) (6) 1. FEATURES BACT/ALERT FA PLASTIC BACT/ALERT FA GLASS CULTURE BOTTLE CULTURE BOTTLE (K992400) Intended Use Same Same Culture Bottle Material | Plastic Glass Product Code MDB MDB Technology Reflectance Reflectance Color cha… | 1999 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121461 | Bact/Alert FA Plus Culture Bottle | 2013 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 24, 2015 | Class II | Z-0750-2016 | Packaging process control | Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance. |
| Apr 13, 2011 | Not classified | Z-2244-2011 | Other | The charcoal suspension in a portion of the lot does not meet the intended density. |
| Jan 11, 2007 | Not classified | Z-0643-2007 | Other | Bacillus sp. contamination was detected in inoculated and uninoculated bottles of BacT/ALERT FA Culture bottles. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K121461 (bioMerieux, Inc., 2013) 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 | — |
What is it indicated for?
BacT/ALERT® FA Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and fungi) from blood, and other normally sterile body fluids.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020813 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020813: Bact/Alert FA Culture Bottle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020813
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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