510(k) · Cleared
ClearedVizion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trek Diagnostic Systems · JWY Manual Antimicrobial Susceptibility Test Systems
Cleared on Nov 16, 2011 after a 99-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Nov 16, 2011
- Review
- 99 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. 2011, 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 Sensititre® Vizion® is an instrument that takes a digital image of a Sensititre® susceptibility plate and magnifies it through the use of a dedicated software and a monitor. The Sensititre® Vizion® is an alternate manual reading method for the Sensititre® MIC plates for non-fastidious Gram positive, Gram negative and fastidious organisms comprising of Hczemophilus influenzae, Streptococci pneumoniae and Streptococci other than S. pneumoniae and…
Read the full statement (167 words)
The Sensititre® Vizion® is an instrument that takes a digital image of a Sensititre® susceptibility plate and magnifies it through the use of a dedicated software and a monitor. The Sensititre® Vizion® is an alternate manual reading method for the Sensititre® MIC plates for non-fastidious Gram positive, Gram negative and fastidious organisms comprising of Hczemophilus influenzae, Streptococci pneumoniae and Streptococci other than S. pneumoniae and Candida spp.
NOTE: Please refer to the Sensititre® 18-24 hour MIC or Breakpoint Susceptibility System package insert and the YeastOne package insert for additional instructions, limitations, and references.
This 510(k) is for the addition of: “Vizion® for reading Sensititre YeastOne Plates”
The Vizion® captures an image of a Sensititre 96 well micro-titre susceptibility plate and projects it onto a touch screen monitor. The user determines the MIC by visually looking for the color change as indicated in the YeastOne technical insert.
The “Vizion” can be used as an alternate method where the user manually reads the MIC result on the Sensititre System.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K112276 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112276: Vizion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112276
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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