510(k) · Cleared
ClearedThe Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermo Fisher Scientific · NGZ Susceptibility Test Plate, Antifungal
Cleared on Jan 20, 2023 after a 204-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 20, 2023
- Review
- 204 days
- Class
- Class II
- Product code
- NGZ
- 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 NGZ? 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 NGZ device
- #1 K232963 VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >=…score 8.4 · 4 generations · no Class I recall
- #2 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 NGZ devicesNGZ Susceptibility Test Plate, Antifungal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · NGZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NGZ
204in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NGZ
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NGZ
1in 2024
MAUDE reports naming product code NGZ, 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 | 0 | — | 0 | 0 |
| 2009 | 3 | 326 | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 3 | 232 | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 16 |
| 2018 | 1 | — | 0 | 10 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 8 |
| 2022 | 0 | — | 2 | 3 |
| 2023 | 3 | 204 | 0 | 3 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Sensititre YeastOne Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candida spp.
This 510(k) is for Caspofungin with new FDA breakpoints and indications for testing Candida spp. on the Sensititre YeastOne Susceptibility System.
Caspofungin has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label:
Candida albicans
Candida glabrata
Candida krusei
Candida parapsilosis
Candida tropicalis
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K221899 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221899: The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221899
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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