510(k) Report

510(k) · Cleared

Cleared

MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)

K162740510(k) TraditionalCleared Mar 21, 2017172-day reviewClass II21 CFR 866.1640

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Beckman Coulter, Inc. · LTT Panels, Test, Susceptibility, Antimicrobial

Cleared on Mar 21, 2017 as substantially equivalent to K083262 (Siemens Healthcare Diagnostics, 2009) after a 172-day review. Its family tree reaches back 1 generation to 2009. 3 later devices descend from it.

Decided
Mar 21, 2017
Review
172 days
Class
Class II
Product code
LTT
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K083262 (2009). 3 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2017: 3 descendants clearedK083262 · Microscan Dried Gram -Negative Mic/Combo Panels with Tigecycline (0.015- 32 MCG/ML) · Siemens Healthcare Diagnostics · 200920052010201520202025
Descendants, by generation 1 generation forward: 3 descendants K083262 · Microscan Dried Gram -Negative Mic/Combo Panels with Tigecycline (0.015- 32 MCG/ML) · Siemens Healthcare Diagnostics · 20090
  1. Root · 1 generation backK083262 Microscan Dried Gram -Negative Mic/Combo Panels with Tigecycline…Siemens Healthcare Diagnostics · 2009
  2. This deviceK162740 MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 -…Beckman Coulter, Inc. · 2017
  3. Descendant · cites it directly · 0 of its ownK172337 MicroScan Dried Gram Negative MIC/Combo Panels with…Beckman Coulter, Inc. · 2017
  4. Descendant · cites it directly · 0 of its ownK172912 MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S…Beckman Coulter, Inc. · 2017
  5. Descendant · cites it directly · 0 of its ownK172255 MicroScan Dried Gram Negative MIC/Combo Panels with…Beckman Coulter, Inc. · 2017

Most influential descendants

Showing 3 of 3 · See all
  • K172337MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4…Beckman Coulter, Inc. · 2017 · cites it directly0descendants
  • K172912MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8 µg/mL)Beckman Coulter, Inc. · 2017 · cites it directly0descendants
  • K172255MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 -…Beckman Coulter, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K083262Microscan Dried Gram -Negative Mic/Combo Panels with Tigecycline (0.015- 32…Siemens Healthcare Diagnostics2009—
0 (this device)K162740MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)Beckman Coulter, Inc.2017—
+1K172337MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam…Beckman Coulter, Inc.2017—
+1K172912MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8…Beckman Coulter, Inc.2017—
+1K172255MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam…Beckman Coulter, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201730
FIG. 1 — Lineage of K162740, 2009–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K243804 MicroScan Dried Gram-Negative MIC/Combo Panels…score 10.8 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K083262Microscan Dried Gram -Negative Mic/Combo Panels with Tigecycline (0.015- 32 MCG/ML)
Summary page 4
…e: LTT 510(k) Notification: Reformulated antimicrobial - Imipenem Predicate device: MicroScan Dried Gram-Negative MIC/Combo Panels – Tigecycline (K083262) 510(k) Summary: MicroScan Dried Gram-Negative MIC/Combo Panels are designed for use in determining quantitative and/or…
Siemens Healthcare Diagnostics2009—

What descends from it? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K172337MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4…Beckman Coulter, Inc.20170
K172912MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8 µg/mL)Beckman Coulter, Inc.20170
K172255MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 -…Beckman Coulter, Inc.20170

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?

  • Its one ancestor has no recall.
  • Of its descendants, K172337 (Beckman Coulter, Inc., 2017) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LTT devices

LTT 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

2009: 22010: 12011: 12013: 22015: 12017: 42019: 12020: 42025: 3
2007high 4 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LTT

219in 2025

2017: 132 days median2020: 90 days median2025: 219 days median
2007high 219 (2025) · low 90 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LTT

7in 2015

2015: 7
2007high 7 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LTT

3in 2017

2007: 72008: 42009: 12010: 12011: 12013: 52014: 92015: 102016: 12017: 3
2007high 10 (2015) · low 0 (2012)2025

MAUDE reports naming product code LTT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—07
20080—04
20092—01
20101—01
20111—01
20120—00
20132—05
20140—09
20151—710
20160—01
2017413203
20180—00
20191—00
202049000
20210—00
20220—00
20230—00
20240—00
2025321900
20260—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 (119 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 reformulated antimicrobial imipenem at concentrations of 0.25 to 8 μg/ml to the test panel.

The gram-negative organisms which may be used for imipenem susceptibility testing in this panel are:

Acinetobacter spp. Citrobacter spp. Enterobacter spp. Escherichia coli, Klebsiella spp. Morganella morganii, Proteus vulgaris, Providencia rettgeri, and Pseudomonas aeruginosa

Indications for use as stated in the FDA summary.

More from Beckman Coulter, Inc.

456 FDA decisions under this applicant name. See the company

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  • K262109Access NT-proBNPBeckman Coulter, Inc. · 2026
  • K252169Access BNP IIBeckman Coulter, Inc. · 2026
  • K254059Access anti-HBc IgMBeckman Coulter, Inc. · 2026

Recent decisions in LTT

The LTT category page

  • K243804MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)Beckman Coulter, Inc. · 2025
  • K250036MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)Beckman Coulter, Inc. · 2025
  • K250084MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)Beckman Coulter, Inc. · 2025
  • K202343MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )Beckman Coulter, Inc. · 20201 recall
  • K201423MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)Beckman Coulter, Inc. · 2020

https://510kreport.com/device/K162740 · printed Nov 6, 2026

Cite this page

510(k) Report. “K162740: MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 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/K162740

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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