510(k) · Cleared
ClearedMicroscan Dried Gram -Negative Mic/Combo Panels with Tigecycline (0.015- 32 MCG/ML)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · LTT Panels, Test, Susceptibility, Antimicrobial
Cleared on Feb 18, 2009 after a 105-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Feb 18, 2009
- Review
- 105 days
- Class
- Class II
- Product code
- LTT
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK083262 Microscan Dried Gram -Negative Mic/Combo Panels with Tigecycline…Siemens Healthcare Diagnostics · 2009
- Descendant · cites it directly · 3 of its ownK162740 MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 -…Beckman Coulter, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK172337 MicroScan Dried Gram Negative MIC/Combo Panels with…Beckman Coulter, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK172912 MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S…Beckman Coulter, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK172255 MicroScan Dried Gram Negative MIC/Combo Panels with…Beckman Coulter, Inc. · 2017
Most influential descendants
Showing 4 of 4 · See all- K162740MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)Beckman Coulter, Inc. · 2017 · cites it directly3descendants
- K172337MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4…Beckman Coulter, Inc. · 2017 · 2 generations on0descendants
- K172912MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8 µg/mL)Beckman Coulter, Inc. · 2017 · 2 generations on0descendants
- K172255MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 -…Beckman Coulter, Inc. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K083262 | Microscan Dried Gram -Negative Mic/Combo Panels with Tigecycline (0.015- 32… | Siemens Healthcare Diagnostics | 2009 | — |
| +1 | K162740 | MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL) | Beckman Coulter, Inc. | 2017 | — |
| +2 | K172337 | MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam… | Beckman Coulter, Inc. | 2017 | — |
| +2 | K172912 | MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8… | Beckman Coulter, Inc. | 2017 | — |
| +2 | K172255 | MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam… | Beckman Coulter, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 4 | 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 LTT? 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 LTT device
- #1 K243804 MicroScan Dried Gram-Negative MIC/Combo Panels…score 10.8 · 4 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 |
|---|---|---|---|
| * | — | MicroScan Dried Gram-Negative MIC/Combo Panels Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162740 | MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL) | 2017 | 3 |
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?
- Of its descendants, K162740 (Beckman Coulter, Inc., 2017) has gone furthest, with 3 descendants of its own.
How does its category compare?
All LTT devicesLTT Panels, Test, Susceptibility, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · LTT
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LTT
219in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LTT
7in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LTT
3in 2017
MAUDE reports naming product code LTT, 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 | — | 0 | 7 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 9 |
| 2015 | 1 | — | 7 | 10 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 4 | 132 | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 4 | 90 | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 3 | 219 | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MicroScan® Dried Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli. After inoculation, panels are incubated for 16 -20 hours at 35°C +/-1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert. This particular…
Read the full statement (107 words)
The MicroScan® Dried Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli. After inoculation, panels are incubated for 16 -20 hours at 35°C +/-1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.
This particular submission is for the addition of the antimicrobial Tigecycline at concentrations of 0.015 to 32 mcg/ml to the test panel.
The gram-negative organisms which may be used for Tigecycline susceptibility testing in this panel are:
Citrobacter freundii
Enterobacter cloacae
Escherichia coli
Klebsiella oxytoca
Klebsiella pneumoniae
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083262 · printed Nov 3, 2026
Cite this page
510(k) Report. “K083262: Microscan Dried Gram -Negative Mic/Combo Panels with Tigecycline (0.015- 32 MCG/ML).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K083262
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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