510(k) · Cleared
Recalled · Class II · 2026LabPro Data Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Cleared on Aug 30, 2020 as substantially equivalent to K070346 (Dade Behring, Inc., 2007) after a 94-day review. Its family tree reaches back 3 generations to 2002. It has been recalled 2 times.
- Decided
- Aug 30, 2020
- Review
- 94 days
- Class
- Class II
- Product code
- LON
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K020322 (2002). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK020322 BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2002
- 2 generations backK040099 BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2004 · Recalled
- 1 generation backK070346 Dade Behring Labpro Alert Software SystemDade Behring, Inc. · 2007
- This deviceK201405 LabPro Data Management SystemBeckman Coulter, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K020322 | BD Phoenix Automated Microbiology System | Becton, Dickinson & CO | 2002 | — |
| −2 | K040099 | BD Phoenix Automated Microbiology System | Becton, Dickinson & CO | 2004 | 4 |
| −1 | K070346 | Dade Behring Labpro Alert Software System | Dade Behring, Inc. | 2007 | — |
| 0 (this device) | K201405 | LabPro Data Management System | Beckman Coulter, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 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 LON? 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 LON device
- #1 K260619 VITEK 2 AST-Streptococcus Cefepime (<=0.06 –…score 13.3 · 5 generations · 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 |
|---|---|---|---|
| * | K070346 | Dade Behring Labpro Alert Software SystemSummary page 4…dicate Device Information: Trade Name: Dade Behring LabPro Data Management System v3.01 Common Name: LabPro 510(k) Number: K070346 Classification Regulation: 866.1645 Product Code: LON Device: System, Test, Automated, Anti… | 2007 |
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 26, 2026 | Class II | Z-2888-2026 | Software Design Change | Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications." |
| Jun 26, 2026 | Class II | Z-2889-2026 | Software Design Change | Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications." |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 5 ancestors have a recall of any class.
How does its category compare?
All LON devicesLON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · LON
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LON
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LON
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LON
690in 2025
MAUDE reports naming product code LON, 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 | 19 | 50 | 0 | 3 |
| 2008 | 7 | 66 | 1 | 1 |
| 2009 | 8 | 76 | 0 | 0 |
| 2010 | 1 | — | 116 | 3 |
| 2011 | 8 | 85 | 3 | 4 |
| 2012 | 10 | 200 | 3 | 9 |
| 2013 | 7 | 115 | 0 | 3 |
| 2014 | 4 | 90 | 2 (2) | 10 |
| 2015 | 0 | — | 0 | 41 |
| 2016 | 3 | 242 | 2 | 94 |
| 2017 | 10 | 89 | 1 | 197 |
| 2018 | 4 | 88 | 6 | 512 |
| 2019 | 8 | 84 | 1 | 315 |
| 2020 | 5 | 81 | 8 | 218 |
| 2021 | 5 | 268 | 0 | 232 |
| 2022 | 8 | 189 | 15 | 180 |
| 2023 | 11 | 210 | 0 | 453 |
| 2024 | 2 | — | 1 | 418 |
| 2025 | 5 | 90 | 1 | 690 |
| 2026 | 4 | 146 | 6 | — |
What is it indicated for?
LabPro Data Management System is a Microsoft® Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from Beckman Coulter instruments or manually entered microbiology test results, for use by trained laboratory personnel. LabPro AlertEx is a functional subset of the LabPro Data Management System that analyzes Beckman Coulter ID and AST data, or other…
Read the full statement (146 words)
LabPro Data Management System is a Microsoft® Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from Beckman Coulter instruments or manually entered microbiology test results, for use by trained laboratory personnel.
LabPro AlertEx is a functional subset of the LabPro Data Management System that analyzes Beckman Coulter ID and AST data, or other pre-defined parameters, against a series of established rules/ alerts and notifies the user of unusual, and/or critical conditions, which may warrant further analysis or action.
LabPro-MBT software is a functional subset of LPDMS intended to electronically transfer and display organism identifications from the Bruker MALDI Biotyper System to the LabPro Data Management System. LabPro-MBT software is a device that is intended to electronically transfer medical device data, without controlling or altering the functions or parameters of any connected medical devices.
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/K201405 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201405: LabPro Data Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201405
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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