510(k) Report

510(k) · Cleared

Cleared

MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)

K193536510(k) TraditionalCleared Mar 18, 202089-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 18, 2020 as substantially equivalent to K192355 (Beckman Coulter, Inc., 2019) after an 89-day review. Its family tree reaches back 2 generations to 2019. 3 later devices descend from it.

Decided
Mar 18, 2020
Review
89 days
Class
Class II
Product code
LTT
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K190109 (2019). 3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2020: 1 descendant cleared2025: 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. · 2019201620182020202220242026
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants K192355 · 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 · 2 generations backK190109 MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline…Beckman Coulter, Inc. · 2019
  2. 1 generation backK192355 MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer)…Beckman Coulter, Inc. · 2019
  3. This deviceK193536 MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin…Beckman Coulter, Inc. · 2020
  4. Descendant · cites it directly · 2 of its ownK202343 MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime…Beckman Coulter, Inc. · 2020 · Recalled
  5. Descendant · 2 generations on · 0 of its ownK243804 MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE)…Beckman Coulter, Inc. · 2025
  6. Descendant · 2 generations on · 0 of its ownK250084 MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT)…Beckman Coulter, Inc. · 2025

Most influential descendants

Showing 3 of 3 · See all
  • K202343MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )Beckman Coulter, Inc. · 2020 · cites it directly2descendants
  • K243804MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL)…Beckman Coulter, Inc. · 2025 · 2 generations on0descendants
  • K250084MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)Beckman Coulter, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K190109MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV)…Beckman Coulter, Inc.2019—
−1K192355MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer)…Beckman Coulter, Inc.2019—
0 (this device)K193536MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004…Beckman Coulter, Inc.2020—
+1K202343MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64…Beckman Coulter, Inc.20201
+2K243804MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64…Beckman Coulter, Inc.2025—
+2K250084MicroScan 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
202010
202520
FIG. 1 — Lineage of K193536, 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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K192355MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL)
Summary page 5
…Code: LTT 510(k) Notification: Updated Breakpoints – Ciprofloxacin Predicate device: MicroScan Dried Gram-Negative MIC/Combo Panels Meropenem – (K192355) 510(k) Summary: MicroScan Dried Gram-Negative MIC/Combo Panels are designed for use in determining quantitative and/or…
Beckman Coulter, Inc.2019—

Also cleared against K192355: 2 other devices →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K202343MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )Beckman Coulter, Inc.20202

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 1 year and passes through 1 company; a new generation was cleared every 7 months on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K202343 (Beckman Coulter, Inc., 2020) has gone furthest, with 2 descendants of its own.
  • 2 other devices also cite its predicate K192355.

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.

Also cleared against K192355

2 other devices cite the same predicate.

  • K201423MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)Beckman Coulter, Inc. · 2020
  • K193358MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL)Beckman Coulter, Inc. · 2020

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
  • 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/K193536 · printed Nov 5, 2026

Cite this page

510(k) Report. “K193536: MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193536

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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