510(k) · Cleared
ClearedMicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · LTT Panels, Test, Susceptibility, Antimicrobial
Cleared on Dec 15, 2017 as substantially equivalent to K162740 (Beckman Coulter, Inc., 2017) after a 135-day review. Its family tree reaches back 2 generations to 2009.
- Decided
- Dec 15, 2017
- Review
- 135 days
- Class
- Class II
- Product code
- LTT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K083262 (2009). No later device cites it as a predicate yet.
- Root · 2 generations backK083262 Microscan Dried Gram -Negative Mic/Combo Panels with Tigecycline…Siemens Healthcare Diagnostics · 2009
- 1 generation backK162740 MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 -…Beckman Coulter, Inc. · 2017
- This deviceK172337 MicroScan Dried Gram Negative MIC/Combo Panels with…Beckman Coulter, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K172337 | MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam… | Beckman Coulter, Inc. | 2017 | — |
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 |
|---|---|---|---|
| * | K162740 | MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)Summary page 4…LTT 510(k) Notification: New antimicrobial agent – Ceftazidime/Avibactam Predicate device: MicroScan Dried Gram-Negative MIC/Combo Panels – Imipenem (K162740) 510(k) Summary: MicroScan Dried Gram-Negative MIC/Combo Panels are designed for use in determining quantitative and/or… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 8 years and passes through 2 companies; a new generation was cleared every 8.1 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K162740.
How does its category compare?
All LTT devicesLTT Panels, Test, Susceptibility, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 (127 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 ceftazidime/avibactam at concentrations of 0.25/4 to 64/4 μg/mL to the test panel.
The gram-negative organisms which may be used for ceftazidime/avibactam susceptibility testing in this panel are:
Citrobacter freundii complex, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Pseudomonas aeruginosa, Providencia rettgeri, Providencia stuartii, and Serratia marcescens
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172337: MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172337
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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