510(k) · Cleared
Recalled · 2006Bact/Alert (TM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Organon Teknika Corp. · MDB System, Blood Culturing
Cleared on Mar 12, 1991 after a 221-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled 6 times.
- Decided
- Mar 12, 1991
- Review
- 221 days
- Class
- Class I
- Product code
- MDB
- Recalls
- 6
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK903505 Bact/Alert (TM)Organon Teknika Corp. · 1991
- Descendant · cites it directly · 0 of its ownK161816 BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO…bioMerieux, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK973305 Bact/Alert Culture BottlesOrganon Teknika Corp. · 1997
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 |
|---|---|---|---|---|---|
| 0 (this device) | K903505 | Bact/Alert (TM) | Organon Teknika Corp. | 1991 | — |
| +1 | K161816 | BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO | bioMerieux, Inc. | 2017 | — |
| +1 | K973305 | Bact/Alert Culture Bottles | Organon Teknika Corp. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 19, 2006 | Not classified | Z-0644-2007 | Other | Bottle data is not sent to BacT/ALERT 3D instrument. |
| Aug 14, 2006 | Not classified | Z-0773-2007 | Other | Plastic bottle samples assigned less sensitive default glass bottle algorithm instead of the plastic bottle algorithm on BacT/ALERT Microbial Detection Systems. |
| May 27, 2005 | Not classified | Z-0612-05 | Other | A Bac T/ALERT 3D system failed to detect a positive sample in a pediatric BAC T/ALERT PF bottle. |
| May 27, 2005 | Not classified | Z-0613-05 | Other | A Bac T/ALERT 3D system failed to detect a positive sample in a pediatric BAC T/ALERT PF bottle. |
| May 27, 2005 | Not classified | Z-0614-05 | Other | A Bac T/ALERT 3D system failed to detect a positive sample in a pediatric BAC T/ALERT PF bottle. |
| Sep 17, 2004 | Not classified | Z-0456-05 | Other | Over heating of memory board. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K161816 (bioMerieux, Inc., 2017) 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.
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 | — |
https://510kreport.com/device/K903505 · printed Nov 6, 2026
Cite this page
510(k) Report. “K903505: Bact/Alert (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K903505
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026