510(k) Report

510(k) · Cleared

Cleared

MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL)

K192355510(k) TraditionalCleared Nov 14, 201977-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. · JWY Manual Antimicrobial Susceptibility Test Systems

Cleared on Nov 14, 2019 as substantially equivalent to K190109 (Beckman Coulter, Inc., 2019) after a 77-day review. Its family tree reaches back 1 generation to 2019. 6 later devices descend from it.

Decided
Nov 14, 2019
Review
77 days
Class
Class II
Product code
JWY
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K190109 (2019). 6 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2020: 4 descendants cleared2025: 2 descendants clearedK190109 · MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) · Beckman Coulter, Inc. · 2019201620182020202220242026
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 1 descendant3 generations forward: 2 descendants K190109 · MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) · Beckman Coulter, Inc. · 20190
  1. Root · 1 generation backK190109 MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline…Beckman Coulter, Inc. · 2019
  2. This deviceK192355 MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer)…Beckman Coulter, Inc. · 2019
  3. Descendant · cites it directly · 3 of its ownK193536 MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin…Beckman Coulter, Inc. · 2020
  4. Descendant · 2 generations on · 2 of its ownK202343 MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime…Beckman Coulter, Inc. · 2020 · Recalled
  5. Descendant · 3 generations on · 0 of its ownK243804 MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE)…Beckman Coulter, Inc. · 2025
  6. Descendant · 3 generations on · 0 of its ownK250084 MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT)…Beckman Coulter, Inc. · 2025
  7. Descendant · cites it directly · 0 of its ownK201423 MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer)…Beckman Coulter, Inc. · 2020

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2020: 42025: 2
2020high 4 (2020) · low 0 (2021)2026

Most influential descendants

Showing 5 of 6 · See all
  • K193536MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)Beckman Coulter, Inc. · 2020 · cites it directly3descendants
  • K202343MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )Beckman Coulter, Inc. · 2020 · 2 generations on2descendants
  • K243804MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL)…Beckman Coulter, Inc. · 2025 · 3 generations on0descendants
  • K250084MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)Beckman Coulter, Inc. · 2025 · 3 generations on0descendants
  • K201423MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)Beckman Coulter, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K190109MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV)…Beckman Coulter, Inc.2019—
0 (this device)K192355MicroScan 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—
+2K202343MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64…Beckman Coulter, Inc.20201
+3K243804MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64…Beckman Coulter, Inc.2025—
+3K250084MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64…Beckman Coulter, Inc.2025—
+1K201423MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32…Beckman Coulter, Inc.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202040
202520
FIG. 1 — Lineage of K192355, 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 JWY? 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 JWY device

  1. #1 K260447 ETEST Gepotidacin (GEP) (0.016-256 µg/mL)score 12.7 · 6 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
*K190109MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL)
Summary page 3
…t Code: LTT 510(k) Notification: Updated Breakpoints – Meropenem Predicate device: MicroScan Dried Gram-Negative MIC/Combo Panels Eravacycline – (K190109) 510(k) Summary: MicroScan Dried Gram-Negative MIC/Combo Panels are designed for use in determining quantitative and/or…
Beckman Coulter, Inc.2019—

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K193536MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)Beckman Coulter, Inc.20203
K201423MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)Beckman Coulter, Inc.20200
K193358MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL)Beckman Coulter, Inc.20200

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, K193536 (Beckman Coulter, Inc., 2020) has gone furthest, with 3 descendants of its own.

How does its category compare?

All JWY devices

JWY Manual Antimicrobial Susceptibility Test Systems: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · JWY

14in 2025

2008: 62009: 22010: 42011: 42012: 12014: 62015: 92016: 42017: 142018: 122019: 182020: 52021: 52023: 72024: 62025: 142026 (partial year): 2
2007high 18 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWY

106in 2025

2008: 85 days median2010: 73 days median2011: 125 days median2014: 106 days median2015: 90 days median2016: 88 days median2017: 61 days median2018: 51 days median2019: 60 days median2020: 66 days median2021: 266 days median2023: 85 days median2024: 90 days median2025: 106 days median
2007high 266 (2021) · low 51 (2018)2026

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

Recalls per year · JWY

31in 2022

2008: 12011: 32014: 52015: 6, 4 Class I2017: 22022: 31, 9 Class I
2007high 31 (2022) · low 0 (2007)2026

Class I (13 since 2007) Class II/III not classified

Adverse event reports per year · JWY

1in 2024

2008: 12009: 12014: 42015: 112016: 202017: 92018: 132019: 102020: 202021: 412022: 112023: 92024: 1
2007high 41 (2021) · low 0 (2007)2025

MAUDE reports naming product code JWY, 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—00
200868511
20092—01
201047300
2011412530
20121—00
20130—00
2014610654
20159906 (4)11
2016488020
2017146129
20181251013
20191860010
2020566020
20215266041
20220—31 (9)11
202378509
202469001
20251410600
20262—0—

What is it indicated for?

To determine antimicrobial agent susceptibility

Indications for use as stated in the FDA summary.

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  • K254059Access anti-HBc IgMBeckman Coulter, Inc. · 2026

Recent decisions in JWY

The JWY category page

  • K260447ETEST Gepotidacin (GEP) (0.016-256 µg/mL)bioMérieux SA · 2026
  • K260696MTS Gepotidacin 0.016-256 µg/mLLiofilchem s.r.l. · 2026
  • K252114MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mLLiofilchem s.r.l. · 2025
  • K252062The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of…Thermo Fisher Scientific · 2025
  • K250575The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution…Thermo Fisher Scientific · 2025

https://510kreport.com/device/K192355 · printed Nov 6, 2026

Cite this page

510(k) Report. “K192355: MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192355

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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