510(k) · Cleared
ClearedComASP Cefiderocol 0.008-128
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Liofilchem s.r.l. · JWY Manual Antimicrobial Susceptibility Test Systems
Cleared on May 18, 2023 after an 85-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 18, 2023
- Review
- 85 days
- Class
- Class II
- Product code
- JWY
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
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.
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. 2023, this device’s year, is highlighted.
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 ComASP® Cefiderocol 0.008-128 is a quantitative broth microdilution method intended for the in vitro determination of antimicrobial susceptibility of bacteria. ComASP® Cefiderocol consists of polystyrene microtiter panels containing lyophilized concentrations of cefiderocol and tubes of media (iron depleted cation adjusted Mueller Hinton broth), which are used to determine the minimum inhibitory concentration (MIC) in μg/mL using over overnight…
Read the full statement (130 words)
The ComASP® Cefiderocol 0.008-128 is a quantitative broth microdilution method intended for the in vitro determination of antimicrobial susceptibility of bacteria. ComASP® Cefiderocol consists of polystyrene microtiter panels containing lyophilized concentrations of cefiderocol and tubes of media (iron depleted cation adjusted Mueller Hinton broth), which are used to determine the minimum inhibitory concentration (MIC) in μg/mL using over overnight incubation and manual reading procedures. ComASP® Cefiderocol at concentrations of 0.008-128 μg/mL should be interpreted at 16-20 hours of incubation.
ComASP® Cefiderocol can be used to determine the MIC of cefiderocol against the following microorganisms for which cefiderocol has been shown to be active clinically and in vitro according to the FDA drug approved label:
Acinetobacter baumannii complex
Escherichia coli
Enterobacter cloacae complex
Klebsiella pneumoniae
Proteus mirabilis
Pseudomonas aeruginosa
Serratia marcescens
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K230479 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230479: ComASP Cefiderocol 0.008-128.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230479
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026