510(k) · Cleared
Recalled · Class II · 2025Thermo Scientific Sensititre ARIS HiQ System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermo Fisher Scientific · LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Cleared on Nov 6, 2019 after a 111-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Nov 6, 2019
- Review
- 111 days
- Class
- Class II
- Product code
- LRG
- Recalls
- 1
- 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 LRG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 12, 2025 | Class II | Z-1395-2025 | Nonconforming Material/Component | Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LRG devicesLRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · LRG
2in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · LRG
144in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LRG
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LRG
1in 2025
MAUDE reports naming product code LRG, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 13 |
| 2009 | 0 | — | 0 | 11 |
| 2010 | 1 | — | 0 | 12 |
| 2011 | 4 | 144 | 0 | 11 |
| 2012 | 0 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 31 |
| 2015 | 0 | — | 0 | 30 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 3 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Thermo Scientific Sensititre ARIS HiQQ System is part of the Sensititre AST system and is an automated plate management device containing an incubator and embedded OptiRead module. The Thermo Scientific Sensititre ARIS HiQ System is designed for use with the Thermo Scientific Sensititre SWIN Software System. The ARIS HiQ and the SWIN system work together to read Sensititre (18-24 hr) susceptibility plates, generating minimum inhibitory concentration (MIC) and interpreting breakpoint (BP) results for non-fastidious and fastidious microorganisms.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K191918 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191918: Thermo Scientific Sensititre ARIS HiQ System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191918
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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