510(k) · Cleared
ClearedBact/Alert PF 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 K992401 (Organon Teknika Corp., 1999) after a 28-day review. Its family tree reaches back 1 generation to 1999. 2 later devices descend from it.
- Decided
- Apr 18, 2002
- Review
- 28 days
- Class
- Class I
- Product code
- MDB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992401 (1999). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK992401 Bact/Alert PFOrganon Teknika Corp. · 1999
- This deviceK020923 Bact/Alert PF Culture BottlebioMerieux, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK121446 Bact/Alert PF 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 | K992401 | Bact/Alert PF | Organon Teknika Corp. | 1999 | — |
| 0 (this device) | K020923 | Bact/Alert PF Culture Bottle | bioMerieux, Inc. | 2002 | — |
| +1 | K121446 | Bact/Alert PF 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 |
|---|---|---|---|
| * | K992401 | Bact/Alert PFSummary page 2…nd/or differences with marketed device are listed in Table (a) (6) 1. TABLE (a)(6).1 FEATURES BACT/ALERT PF PLASTIC CULTURE | BACT/ALERT PF GLASS BOTTLE CULTURE BOTTLE (K992401) 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 |
|---|---|---|---|
| K121446 | Bact/Alert PF Plus Culture Bottle | 2013 | 1 |
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.
- Of its descendants, K121446 (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?
The BacT/ALERT PF 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 yeast) from blood.
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/K020923 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020923: Bact/Alert PF 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/K020923
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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