510(k) · Cleared
ClearedDried Gram Negative Mic/Combo Panels
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Microscan, Inc. · JWY Manual Antimicrobial Susceptibility Test Systems
Cleared on Mar 22, 2002 after a 77-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Mar 22, 2002
- Review
- 77 days
- Class
- Class II
- Product code
- JWY
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK020037 Dried Gram Negative Mic/Combo PanelsDade Microscan, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK061687 Microscan Dried Gram Negative Mic/Combo PanelsDade Behring, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK061536 Microscan Dried Gram Negative Mic/Combo PanelsDade Behring, Inc. · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020037 | Dried Gram Negative Mic/Combo Panels | Dade Microscan, Inc. | 2002 | — |
| +1 | K061687 | Microscan Dried Gram Negative Mic/Combo Panels | Dade Behring, Inc. | 2006 | — |
| +1 | K061536 | Microscan Dried Gram Negative Mic/Combo Panels | Dade Behring, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 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 MIC/Combo Panels Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K061687 (Dade Behring, Inc., 2006) 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® ESBL plus ESBL Confirmation Panel is designed for use in the determination of antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing gram negative bacilli and for the detection of ESBL production in Escherichia coli, Klebsiella oxytoca and Klebsiella pneumoniae. After inoculation, panels are incubated for a minimum of 16 hours at 35°C in a non-CQO, incubator, and read visually, according to the Package…
Read the full statement (121 words)
The MicroScan® ESBL plus ESBL Confirmation Panel is designed for use in the determination of antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing gram negative bacilli and for the detection of ESBL production in Escherichia coli, Klebsiella oxytoca and Klebsiella pneumoniae. After inoculation, panels are incubated for a minimum of 16 hours at 35°C in a non-CQO, incubator, and read visually, according to the Package Insert.
This particular submission is for the addition of the antimicrobials Ceftazidime (0.5-128 pg/ml), Cefotaxime (0.5-128 pg/ml), Ceftazidime/Clavulanic Acid (0.12/4-32/4 ng/ml) and Cefotaxime/Clavulanic Acid (0.12/4-32/4 pg/ml) to the test panel.
The Gram-Negative organisms which may be used for detection of ESBL production in this panel are:
Escherichia coli
Klebsiella oxytoca
Klebsiella pneumoniae
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020037 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020037: Dried Gram Negative Mic/Combo Panels.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020037
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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