510(k) · Cleared
ClearedDade Behring Labpro Alert Software System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Cleared on Jul 18, 2007 as substantially equivalent to K040099 (Becton, Dickinson & CO, 2004) after a 162-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it.
- Decided
- Jul 18, 2007
- Review
- 162 days
- Class
- Class II
- Product code
- LON
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K020322 (2002). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK020322 BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2002
- 1 generation backK040099 BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2004 · Recalled
- This deviceK070346 Dade Behring Labpro Alert Software SystemDade Behring, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK201405 LabPro Data Management SystemBeckman Coulter, Inc. · 2020 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K201405LabPro Data Management SystemBeckman Coulter, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K020322 | BD Phoenix Automated Microbiology System | Becton, Dickinson & CO | 2002 | — |
| −1 | K040099 | BD Phoenix Automated Microbiology System | Becton, Dickinson & CO | 2004 | 4 |
| 0 (this device) | K070346 | Dade Behring Labpro Alert Software System | Dade Behring, Inc. | 2007 | — |
| +1 | K201405 | LabPro Data Management System | Beckman Coulter, Inc. | 2020 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 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 |
|---|---|---|---|
| * | K040099 | BD Phoenix Automated Microbiology SystemSummary page 1…ing LabPro AlertEl Software System Predicate device: BDXpert System resident on the EpiCenter System (K040099) 510(k) Summary: The Dade Behiring LabPro AlertE, Software System is a rule-based software… | 2004 |
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 |
|---|---|---|---|
| K201405 | LabPro Data Management System | 2020 | 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 5 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K201405 (Beckman Coulter, Inc., 2020) has gone furthest, with 0 descendants of its own.
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. 2007, 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?
The Dade Behring LabPro AlertEx Software System is intended for use with the LabPro Data Management System Software, version 3.0 and MicroScan' Instruments (e.g., WalkAway, S, autoSCAN-4). The AlertEx Software notifies the user of unusual conditions, or out-of-range results that may warrant further analysis or action, and/or provides the user with the ability to change organism identifications and/or antibiotic susceptibility test interpretations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070346 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070346: Dade Behring Labpro Alert Software System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070346
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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