510(k) · Cleared
Recalled · Class II · 2012Bact/Alert SA 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 18, 2002 as substantially equivalent to K993423 (Organon Teknika Corp., 1999) after a 27-day review. Its family tree reaches back 1 generation to 1999. It has been recalled once.
- Decided
- Apr 18, 2002
- Review
- 27 days
- Class
- Class I
- Product code
- MDB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993423 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK993423 Bact/Alert SAOrganon Teknika Corp. · 1999
- This deviceK020931 Bact/Alert SA Culture BottlebioMerieux, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993423 | Bact/Alert SA | Organon Teknika Corp. | 1999 | — |
| 0 (this device) | K020931 | Bact/Alert SA Culture Bottle | bioMerieux, Inc. | 2002 | — |
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 |
|---|---|---|---|
| * | K993423 | Bact/Alert SASummary page 2…/or differences with marketed device are listed in Table (a) (6) 1. TABLE (a) (6) 1. FEATURES BACT/ALERT SA PLASTIC BACT/ALERT SA GLASS CULTURE BOTTLE CULTURE BOTTLE (K993423) Intended Use Same Same Culture Bottle Material | Plastic Glass Product Code MDB MDB Technology Reflectance Reflectance Color cha… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 25, 2012 | Class II | Z-0738-2013 | Nonconforming Material/Component | BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors. |
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.
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 SA Culture Bottles are used with the BacT/ALERT
Microbial Detection Systems in qualitative procedures for the recovery and
detection of aerobic 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/K020931 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020931: Bact/Alert SA 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/K020931
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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