# K254066: Etiometry Platform

- Pathway: 510(k) (Special)
- Applicant: Etiometry, Inc.
- Decided: Apr 3, 2026 after 106 days
- Product code: PPW (Adjunctive Cardiovascular Status Indicator)
- Device class: 2
- Regulation: 21 CFR 870.2200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K962603 (1997). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241479: Etiometry Platform (DAV 5.4 RAE 9.2), Etiometry, Inc. (2025) Summary page 7.

## Indications for use
The Etiometry Platform TM software features the Data Aggregation & Visualization software module version 5.8 and the Risk Analytics Engine software module version 9.4. The Data Aggregation & Visualization software module is intended to record and display multiple physiological parameters of adult, pediatric, and neonatal patients from supported bedside devices. The software module is not intended for alarm notification, nor is it intended to control any of the independent bedside devices to which it is connected. The software module is intended to be used by healthcare professionals for the following purposes: - To remotely consult regarding a patient's status and - To remotely review other standard or critical near real-time patient data in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner. The Data Aggregation & Visualization software module can display numeric physiologic data and waveforms captured by other medical devices: - Airway flow, volume, and pressure - Arterial blood pressure (invasive and non-invasive, systolic, diastolic, and mean) - Bispectral index (BIS, signal quality index, suppression ratio) - Cardiac Index - Cardiac output - Central venous pressure - Cerebral perfusion pressure - End-tidal CO2 - Heart rate - Heart rate variability - Intracranial pressure - Left atrium pressure - Oxygen saturation (intravascular, regional, SpO2) - Premature ventricular counted beats - Pulmonary artery pressure (systolic, diastolic, and mean) - Pulse pressure variation - Pulse Rate - Respiratory rate - Right atrium pressure - Temperature (rectal, esophageal, tympanic, blood, core, nasopharyngeal, skin) - Umbilical arterial pressure (systolic, diastolic, and mean) - Electrocardiogram - Plethysmograph The Data Aggregation & Visualization software module can display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid. The Data Aggregation & Visualization software module can display information captured by the Risk Analytics Engine software module. The Risk Analytics Engine software module calculates four indices: the IDO2 Index™ for inadequate delivery of oxygen, the IVCO2 Index™ for inadequate ventilation of carbon dioxide, the ACD Index™ for acidemia, and the HLA Index™ for hyperlactatemia. The IDO2 Index is indicated for use by health care professionals with post-surgical patients 0 to 12 years of age and weighing 2 kg or more under intensive care and patients 18 years of age or older under intensive care and not on Mechanical Circulatory Support. The IDO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the Data Aggregation & Visualization software module. When the IDO2 Index is increasing, it means that there is an increasing risk of inadequate oxygen delivery, and attention should be brought to the patient. The IDO2 Index presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements. The IVCO2 Index is indicated for use by healthcare professionals with invasively ventilated patients 0 to 12 years of age under intensive care. The IVCO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation and Visualization software module. When the IVCO2 Index is increasing, it means that there is an increasing risk of inadequate carbon dioxide ventilation, and attention should be brought to the patient. The IVCO2 Index™ presents partial quantitative information about the patient's respiratory condition, and no therapy or drugs can be administered based solely on the interpretation statements. The ACD Index is indicated for use by health care professionals with invasively ventilated patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The ACD Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the Data Aggregation and Visualization software module. When the ACD Index is increasing, it means that there is an increasing risk of acidemia, and attention should be brought to the patient. The ACD Index presents partial quantitative information about the patient's respiratory condition, and no therapy or drugs can be administered based solely on the interpretation statements. The HLA Index is indicated for use by health care professionals with post-surgical patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The HLA Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the Data Aggregation & Visualization software module. When the HLA Index is increasing, it means that there is an increasing risk of hyperlactatemia, and attention should be brought to the patient. The HLA Index presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements.

Source page: https://510kreport.com/device/K254066
Methodology: https://510kreport.com/methodology