| K-number | K254066 |
| Device name | Etiometry Platform |
| Applicant | Etiometry, Inc. |
| Product code | PPW |
| Device class | Class II |
| Decision date | Apr 3, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.2200 |
The Etiometry Platform is a software-only ICU data aggregation and visualization system that records and displays multiple physiological parameters from bedside devices for adult, pediatric, and neonatal patients. It includes a Risk Analytics Engine that calculates four adjunctive indices (IDO2, IVCO2, ACD, HLA) to indicate risks of inadequate oxygen delivery, inadequate ventilation, acidemia, and hyperlactatemia respectively, intended to aid clinical decision-making without replacing standard monitoring.
The subject device uses the same fundamental software-only data aggregation/visualization and adjunctive analytics platform architecture as the predicate (DAV 5.4 RAE 9.2). New features include: support for institution-defined cardiogenic shock classification within the Clinical Pathways framework, ability to process additional EHR data types, and cybersecurity maintenance updates.
The document references FDA guidance documents on Software as a Medical Device (SaMD) Clinical Evaluation, Cybersecurity in Medical Devices, and ISO 13485 (Design controls, Nonconforming product, Corrective and preventative action). Specific consensus standards citations are not provided in this summary.
View the full FDA submission: accessdata.fda.gov