# K191918: Thermo Scientific Sensititre ARIS HiQ System

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Fisher Scientific
- Decided: Nov 6, 2019 after 111 days
- Product code: LRG (Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Feb 12, 2025 · Class II · Z-1395-2025: Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.

## Indications for use
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.

Source page: https://510kreport.com/device/K191918
Methodology: https://510kreport.com/methodology