510(k) · Cleared
Recalled · Class II · 2014Versatrek
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trek Diagnostic Systems, Inc. · MDB System, Blood Culturing
Cleared on Aug 22, 2003 after a 28-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 2 times.
- Decided
- Aug 22, 2003
- Review
- 28 days
- Class
- Class I
- Product code
- MDB
- Recalls
- 2
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|---|
| Jun 11, 2014 | Class II | Z-2057-2014 | Employee error | Bottles did not provide positive signals within the time frame of the quality control specification for one of two strains of Streptococcus pneumoniae. |
| Jul 23, 2012 | Class III | Z-2323-2012 | Software design | Review of instrument software databases and investigation of two customer reports determined that on rare occasions (less than 0.3%), following the removal of a positive signaling bottle from the VersaTREK instrument, the positive test… |
No ancestor or descendant has a Class I 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?
Blood Culture System (K921637/A): VersaTEK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile body fluids. Myco Detection (K972756): VersaTREK Myco, with VersaTrek Myco GS, and either VersaTREK AS or PANTA added is a selective growth medium for use with either VersaTREK or ESP II Culture System II for the culture recovery of mycobacteria from sterile body specimens and from…
Read the full statement (139 words)
Blood Culture System (K921637/A): VersaTEK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile body fluids.
Myco Detection (K972756): VersaTREK Myco, with VersaTrek Myco GS, and either VersaTREK AS or PANTA added is a selective growth medium for use with either VersaTREK or ESP II Culture System II for the culture recovery of mycobacteria from sterile body specimens and from digested-decontaminated clinical specimens.
Myco modification—Organism Identification (K972772): Organism identification may be determined using nucleic acid probes (AccuProbe®).
Mycobacterium tuberculosis susceptibility testing (K972772): The VersaTREK Myco Susceptibility Kit is intended for qualitative in vitro susceptibility testing of isolated colonies of Mycobacterium tuberculosis with Rifampin, Ethambutol, and Isoniazid on the VersaTREK instrument. Appropriate inoculum sources are prepared from growth on solid agar, such as Middlebrook 7H10 or Lowenstein-Jensen slants, or Middlebrook 7H9 broth.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K032306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032306: Versatrek.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032306
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026