510(k) Report

510(k) · Cleared

Recalled · Class II · 2025

MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )

K202343510(k) TraditionalCleared Nov 16, 202090-day reviewClass II21 CFR 866.1640Recalls 1

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 Nov 16, 2020 as substantially equivalent to K193536 (Beckman Coulter, Inc., 2020) after a 90-day review. Its family tree reaches back 3 generations to 2019. 2 later devices descend from it. It has been recalled once.

Decided
Nov 16, 2020
Review
90 days
Class
Class II
Product code
LTT
Recalls
1
Predicates
1

Its longest line of descent runs back 3 generations to K190109 (2019). 2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2025: 2 descendants clearedK190109 · MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) · Beckman Coulter, Inc. · 2019K192355 · MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL) · Beckman Coulter, Inc. · 2019K193536 · MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL) · Beckman Coulter, Inc. · 2020201620182020202220242026
Descendants, by generation 1 generation forward: 2 descendants K193536 · MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL) · Beckman Coulter, Inc. · 2020K192355 · MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL) · Beckman Coulter, Inc. · 2019K190109 · MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) · Beckman Coulter, Inc. · 20190
  1. Root · 3 generations backK190109 MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline…Beckman Coulter, Inc. · 2019
  2. 2 generations backK192355 MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer)…Beckman Coulter, Inc. · 2019
  3. 1 generation backK193536 MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin…Beckman Coulter, Inc. · 2020
  4. This deviceK202343 MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime…Beckman Coulter, Inc. · 2020
  5. Descendant · cites it directly · 0 of its ownK243804 MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE)…Beckman Coulter, Inc. · 2025
  6. Descendant · cites it directly · 0 of its ownK250084 MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT)…Beckman Coulter, Inc. · 2025

Most influential descendants

Showing 2 of 2 · See all
  • K243804MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL)…Beckman Coulter, Inc. · 2025 · cites it directly0descendants
  • K250084MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)Beckman Coulter, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K190109MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV)…Beckman Coulter, Inc.2019—
−2K192355MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer)…Beckman Coulter, Inc.2019—
−1K193536MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004…Beckman Coulter, Inc.2020—
0 (this device)K202343MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64…Beckman Coulter, Inc.2020—
+1K243804MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64…Beckman Coulter, Inc.2025—
+1K250084MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64…Beckman Coulter, Inc.2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202520
FIG. 1 — Lineage of K202343, 2019–2025Source: 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
*K193536MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)
Summary page 3
…ode: LTT 510(k) Notification: Updated Breakpoints – Ceftazidime Predicate device: MicroScan Dried Gram-Negative MIC/Combo Panels Ciprofloxacin – (K193536) 510(k) Summary: MicroScan Dried Gram-Negative MIC/Combo Panels are designed for use in determining quantitative and/or…
Beckman Coulter, Inc.2020—

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K243804MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL)…Beckman Coulter, Inc.20250
K250084MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)Beckman Coulter, Inc.20250

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 24, 2025Class IIZ-1609-2026Material/Component ContaminationDue to the likely presence of contamination in well(s).

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 1 year and passes through 1 company; a new generation was cleared every 7 months on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K243804 (Beckman Coulter, Inc., 2025) 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. 2020, 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?

To determine antimicrobial agent susceptibility

Indications for use as stated in the FDA summary.

More from Beckman Coulter, Inc.

456 FDA decisions under this applicant name. See the company

  • K262597Access BNP IIBeckman Coulter, Inc. · 2026
  • K261109Access MeMed BVBeckman Coulter, Inc. · 2026
  • 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
  • K201423MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)Beckman Coulter, Inc. · 2020
  • K193536MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)Beckman Coulter, Inc. · 2020

https://510kreport.com/device/K202343 · printed Nov 6, 2026

Cite this page

510(k) Report. “K202343: MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL ).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202343

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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