510(k) · Cleared
ClearedSensititre 18-24 Hours Susceptibility Plates
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trek Diagnostic Systems, Inc. · JWY Manual Antimicrobial Susceptibility Test Systems
Cleared on Feb 3, 2004 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 3, 2004
- Review
- 88 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
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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.
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 Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive organisms. This 510(k) is for the addition of Daptomycin in the dilution range of 0.03 - 64 jig/ml to the Sensititre 18 -24 hour MIC panel for testing gram positive isolates. The approved primary "Indications for Use" and clinical significance of Daptomycin is for: Staphylococcus aureus (including…
Read the full statement (106 words)
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive organisms.
This 510(k) is for the addition of Daptomycin in the dilution range of 0.03 - 64 jig/ml to the Sensititre 18 -24 hour MIC panel for testing gram positive isolates. The approved primary "Indications for Use" and clinical significance of Daptomycin is for: Staphylococcus aureus (including methicillin-resistant strains),Enterococcusfaecalis (vancomycin-susceptible strains only), Streptococcus agalactiaeand Steptococcus pyogenes. In vitro data, without clinical correlation is provided for: Staphylococcus epidermidis (including methicillin-resistant strains) Enterococcus faecalis ( vancomycin-resistant strains), Enterococcus faecium (including vancomycin-resistant strains)and Staphylococcus haemolyticus.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K033522 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033522: Sensititre 18-24 Hours Susceptibility Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033522
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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