510(k) · Cleared
ClearedBact/Alert PF Plus 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 Jan 25, 2013 as substantially equivalent to K020923 (bioMerieux, Inc., 2002) after a 255-day review. Its family tree reaches back 2 generations to 1999. 1 later device descends from it.
- Decided
- Jan 25, 2013
- Review
- 255 days
- Class
- Class I
- Product code
- MDB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K992401 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK992401 Bact/Alert PFOrganon Teknika Corp. · 1999
- 1 generation backK020923 Bact/Alert PF Culture BottlebioMerieux, Inc. · 2002
- This deviceK121446 Bact/Alert PF Plus Culture BottlebioMerieux, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK183166 BacT/ALERT FA Plus; BacT/ALERT PF PlusbioMerieux, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K183166BacT/ALERT FA Plus; BacT/ALERT PF PlusbioMerieux, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K992401 | Bact/Alert PF | Organon Teknika Corp. | 1999 | — |
| −1 | K020923 | Bact/Alert PF Culture Bottle | bioMerieux, Inc. | 2002 | — |
| 0 (this device) | K121446 | Bact/Alert PF Plus Culture Bottle | bioMerieux, Inc. | 2013 | — |
| +1 | K183166 | BacT/ALERT FA Plus; BacT/ALERT PF Plus | bioMerieux, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K020923 | Bact/Alert PF Culture BottleSummary page 2…t every 10 minutes. SUBSTANTIAL EQUIVALENCE INFORMATION Predicate device name(s) BacT/ALERr PF Culture Bottle Predicate device 510(k) number(s) K020923 Comparison with predicate The BacT/ALERT PP Plus Culture Bottle is claimed substantially equivalent to the BacT/ALERT P… | 2002 |
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 |
|---|---|---|---|
| K183166 | BacT/ALERT FA Plus; BacT/ALERT PF Plus | 2019 | 0 |
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 14 years and passes through 2 companies; a new generation was cleared every 10.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K183166 (bioMerieux, Inc., 2019) has gone furthest, with 0 descendants 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. 2013, 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® PF Plus Culture Bottles are used with the BacT/ALERT® Microbial Detection System 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/K121446 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121446: Bact/Alert PF Plus 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/K121446
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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