510(k) · Cleared
ClearedPasco Mic and Mic/ID Panels, Gemifloxacin (Strep)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Diagnostic Systems · JWY Manual Antimicrobial Susceptibility Test Systems
Cleared on Sep 15, 2003 after a 32-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- Sep 15, 2003
- Review
- 32 days
- Class
- Class II
- Product code
- JWY
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK032518 Pasco Mic and Mic/ID Panels, Gemifloxacin (Strep)Bd Diagnostic Systems · 2003
- Descendant · cites it directly · 0 of its ownK033119 Pasco Mic and Mic/ID PanelsPasco Laboratories, Inc. · 2003
Most influential descendants
Showing 1 of 1 · See all- K033119Pasco Mic and Mic/ID PanelsPasco Laboratories, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032518 | Pasco Mic and Mic/ID Panels, Gemifloxacin (Strep) | Bd Diagnostic Systems | 2003 | — |
| +1 | K033119 | Pasco Mic and Mic/ID Panels | Pasco Laboratories, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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?
The FDA summary names no predicate by 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 |
|---|---|---|---|
| K033119 | Pasco Mic and Mic/ID Panels | 2003 | 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, K033119 (Pasco Laboratories, Inc., 2003) 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?
Pasco MIC and MICOD panels are used for quantitatively measuring (with the exception of the BreakpoindID panel which provides qualitative measurement of category results) the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms. This 510(k) notification is for the addition of the antimicrobial Gemifloxacin at…
Read the full statement (139 words)
Pasco MIC and MICOD panels are used for quantitatively measuring (with the exception of the BreakpoindID panel which provides qualitative measurement of category results) the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms.
This 510(k) notification is for the addition of the antimicrobial Gemifloxacin at concentrations of 0.015 - 4 mcg/ml to Pasco Panels for use in testing Streptococcus pneumoniae and Streptococcus spp. other than S. pneumoniae. Gemifloxacin has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobic.
Active In Vitro and in Clinical Infectious Avainst:
Aerobic Gram-positive microorganisms
Streptococcus pneumoniae (including penicillin-resistant strains)
Active In Vitro but their clinical simificance is unknown
Aerobic Gram-positive microorganisms
Streptococcus pyogenes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032518 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032518: Pasco Mic and Mic/ID Panels, Gemifloxacin (Strep).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032518
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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