510(k) · Cleared
ClearedMicroscan Dried Gram-Negative Mic/Combo Panels with Ertapenem (0.002-32 MCG/ML
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · JWY Manual Antimicrobial Susceptibility Test Systems
Cleared on Feb 10, 2004 after a 161-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Feb 10, 2004
- Review
- 161 days
- Class
- Class II
- Product code
- JWY
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK032706 Microscan Dried Gram-Negative Mic/Combo Panels with Ertapenem…Dade Behring, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK101425 Microscan Dried Gram-Negative Mic/Combo Panel, B1017 Panel SeriesSiemens Healthcare Diagnostics · 2010
Most influential descendants
Showing 1 of 1 · See all- K101425Microscan Dried Gram-Negative Mic/Combo Panel, B1017 Panel SeriesSiemens Healthcare Diagnostics · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032706 | Microscan Dried Gram-Negative Mic/Combo Panels with Ertapenem (0.002-32 MCG/ML | Dade Behring, Inc. | 2004 | — |
| +1 | K101425 | Microscan Dried Gram-Negative Mic/Combo Panel, B1017 Panel Series | Siemens Healthcare Diagnostics | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
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 K260447 ETEST Gepotidacin (GEP) (0.016-256 µg/mL)score 12.7 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | MicroScan Dried Gram-Negative and Gram-Positive MIC/Combo Panels Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101425 | Microscan Dried Gram-Negative Mic/Combo Panel, B1017 Panel Series | 2010 | 0 |
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, K101425 (Siemens Healthcare Diagnostics, 2010) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JWY devicesJWY Manual Antimicrobial Susceptibility Test Systems: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JWY
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWY
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWY
31in 2022
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · JWY
1in 2024
MAUDE reports naming product code JWY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 6 | 85 | 1 | 1 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 4 | 73 | 0 | 0 |
| 2011 | 4 | 125 | 3 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 6 | 106 | 5 | 4 |
| 2015 | 9 | 90 | 6 (4) | 11 |
| 2016 | 4 | 88 | 0 | 20 |
| 2017 | 14 | 61 | 2 | 9 |
| 2018 | 12 | 51 | 0 | 13 |
| 2019 | 18 | 60 | 0 | 10 |
| 2020 | 5 | 66 | 0 | 20 |
| 2021 | 5 | 266 | 0 | 41 |
| 2022 | 0 | — | 31 (9) | 11 |
| 2023 | 7 | 85 | 0 | 9 |
| 2024 | 6 | 90 | 0 | 1 |
| 2025 | 14 | 106 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The MicroScan® Dried Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli. After inoculation, panels are incubated for 16 - 20 hours at 350C +/- 10C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert. This particular…
Read the full statement (119 words)
The MicroScan® Dried Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli. After inoculation, panels are incubated for 16 - 20 hours at 350C +/- 10C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.
This particular submission is for the addition of the antimicrobial Ertapenem at concentrations of 0.002 to 32 mcg/mI to the test panel.
The gram-negative organisms which may be used for Ertapenem susceptibility testing in this panel are:
Citrobacterfreundii
Citrobacterkoseri
Enterobacteraerogenes
Enterobactercloacae
Escherichiacoli
Klebsiella oxytoca (excluding ESBL producing strains)
Klebsiella pneumoniae
Morganella morganii
Proteus mirabilis
Proteus vulgaris
Serratiamarcescens
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032706 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032706: Microscan Dried Gram-Negative Mic/Combo Panels with Ertapenem (0.002-32 MCG/ML.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032706
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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