510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Microdilution Panels

K862140510(k) TraditionalCleared Jul 16, 198642-day reviewClass II21 CFR 866.1640Recalls 4

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

American Micro Scan · JWY Manual Antimicrobial Susceptibility Test Systems

Cleared on Jul 16, 1986 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 4 times.

Decided
Jul 16, 1986
Review
42 days
Class
Class II
Product code
JWY
Recalls
4
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K862140Source: FDA 510(k) database · 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
May 14, 2014Class IIZ-1522-2015Equipment maintenanceSiemens Healthcare Diagnostics has received complaints regarding panel degradation with a portion of the MicroScan Neg Breakpoint Combo 34 (NBP34) panel lot 2014-05-28.
Jun 16, 2011Not classifiedZ-1498-2012Process controlThree lots were confirmed to not meet performance claims due to random non-biological contamination which is only apparent (precipated) after inoculation of the panels.
Jun 16, 2011Not classifiedZ-1499-2012Process controlThree lots were confirmed to not meet performance claims due to random non-biological contamination which is only apparent (precipated) after inoculation of the panels
Jun 16, 2011Not classifiedZ-1497-2012Process controlThree lots were confirmed to not meet performance claims due to random non-biological contamination which is only apparent (precipated) after inoculation of the panels.

No ancestor or descendant has a Class I recall.

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.

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—

More from American Micro Scan

36 FDA decisions under this applicant name. See the company

  • K870029Immunoscan (TM) Direct Streptococcus PneumoniaeAmerican Micro Scan · 1987
  • K864662Chlamydiae Fluor. AB Test for Detection in SmearsAmerican Micro Scan · 1987
  • K863776Microdilution Mic PanelsAmerican Micro Scan · 1987
  • K864674Microdilution Identification PanelsAmerican Micro Scan · 1987
  • K864389Chlamydiae Flourescent Monoclonal Antibody TestAmerican Micro Scan · 1986

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/K862140 · printed Nov 6, 2026

Cite this page

510(k) Report. “K862140: Microdilution Panels.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K862140

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026