510(k) Report

510(k) · Cleared

Cleared

Streptococcus Mic Panel

K963641510(k) TraditionalCleared Dec 18, 199697-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

Dade Microscan, Inc. · JWY Manual Antimicrobial Susceptibility Test Systems

Cleared on Dec 18, 1996 after a 97-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 36 later devices descend from it.

Decided
Dec 18, 1996
Review
97 days
Class
Class II
Product code
JWY
Recalls
None
Predicates
0

36 later devices descend from it, 22 citing it directly.

Descendants, by year cleared 2002: 19 descendants cleared2000: 3 descendants cleared2006: 10 descendants cleared2011: 3 descendants cleared2021: 1 descendant cleared1995200020052010201520202025
  1. This deviceK963641 Streptococcus Mic PanelDade Microscan, Inc. · 1996
  2. Descendant · cites it directly · 4 of its ownK020556 Microscan Microstrep Plus Panel with LevofloxacinDade Microscan, Inc. · 2002
  3. Descendant · cites it directly · 1 of its ownK021169 Microstrep Plus Panel, AzithromycinDade Microscan, Inc. · 2002
  4. Descendant · cites it directly · 1 of its ownK021110 Microscan Microstrep Plus Panel New Antimicrobial- CeftriaxoneDade Microscan, Inc. · 2002
  5. Descendant · cites it directly · 1 of its ownK021111 Microscan Microstrep Plus Panel New Antimicrobial - CefotaximeDade Microscan, Inc. · 2002
  6. Descendant · cites it directly · 1 of its ownK021188 Microscan Microstrep Plus Panel New Antimicrobial-CefepimeDade Microscan, Inc. · 2002

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

2000: 32002: 192006: 102011: 32021: 1
2000high 19 (2002) · low 0 (2001)2026

Most influential descendants

Showing 5 of 36 · See all
  • K020556Microscan Microstrep Plus Panel with LevofloxacinDade Microscan, Inc. · 2002 · cites it directly4descendants
  • K021169Microstrep Plus Panel, AzithromycinDade Microscan, Inc. · 2002 · cites it directly1descendant
  • K021110Microscan Microstrep Plus Panel New Antimicrobial- CeftriaxoneDade Microscan, Inc. · 2002 · cites it directly1descendant
  • K021111Microscan Microstrep Plus Panel New Antimicrobial - CefotaximeDade Microscan, Inc. · 2002 · cites it directly1descendant
  • K021188Microscan Microstrep Plus Panel New Antimicrobial-CefepimeDade Microscan, Inc. · 2002 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K963641Streptococcus Mic PanelDade Microscan, Inc.1996—
+1K020556Microscan Microstrep Plus Panel with LevofloxacinDade Microscan, Inc.2002—
+1K021169Microstrep Plus Panel, AzithromycinDade Microscan, Inc.2002—
+1K021110Microscan Microstrep Plus Panel New Antimicrobial- CeftriaxoneDade Microscan, Inc.2002—
+1K021111Microscan Microstrep Plus Panel New Antimicrobial - CefotaximeDade Microscan, Inc.2002—
+1K021188Microscan Microstrep Plus Panel New Antimicrobial-CefepimeDade Microscan, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200030
2002190
2006100
201130
202110
FIG. 1 — Lineage of K963641, 1996–2021Source: 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), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (36)

See all 36

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

NumberDeviceApplicantDecidedDescendants
K020556Microscan Microstrep Plus Panel with LevofloxacinDade Microscan, Inc.20024
K021169Microstrep Plus Panel, AzithromycinDade Microscan, Inc.20021
K021110Microscan Microstrep Plus Panel New Antimicrobial- CeftriaxoneDade Microscan, Inc.20021
K021111Microscan Microstrep Plus Panel New Antimicrobial - CefotaximeDade Microscan, Inc.20021
K021188Microscan Microstrep Plus Panel New Antimicrobial-CefepimeDade Microscan, Inc.20021
K020938Microscan Microstrep Plus Panel-MeropenemDade Microscan, Inc.20021
K020939Microscan Microstrep Plus Panel-TetracyclineDade Microscan, Inc.20021
K020820Microscan Microstep Plus Panel New Antimicrobial - CefuroximeDade Behring, Inc.20021
K020822Microscan Microstep Plus Panel New Antimicrobial - VancomycinDade Behring, Inc.20021
K020937Microscan Microstrep Plus Panel-Amoxicillin/Clavulanic AcidDade Microscan, Inc.20021

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?

  • Of its descendants, K020556 (Dade Microscan, Inc., 2002) has gone furthest, with 4 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.

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 Dade Microscan, Inc.

40 FDA decisions under this applicant name. See the company

  • K043589Microscan Dried Gram-Positive Mic/Combo Panels - ErtapenemDade Microscan, Inc. · 2005
  • K023202Microscan Synergies PlusDade Microscan, Inc. · 2002
  • K021184Microscan Microstrep Plus Panel New Antimicrobial-ClindamycinDade Microscan, Inc. · 2002
  • K021181Microscan Microstrep Plus Panel New Anticrobial-ClarithromycinDade Microscan, Inc. · 2002
  • K021018Microscan Microstrep Plus Panel - ChloramphenicolDade Microscan, Inc. · 2002

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/K963641 · printed Nov 4, 2026

Cite this page

510(k) Report. “K963641: Streptococcus Mic Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963641

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