# K142732: T3 Software

- Pathway: 510(k) (Traditional)
- Applicant: Etiometry, Inc.
- Decided: Mar 4, 2015 after 162 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K991684 (2000). 13 ancestors in all.
18 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140339: Vital Sync Informatics Manager & Virtual Patient Monitoring Platform, Covidien (2014) Summary page 5.
- K132604: Vital Sync Informatics Manager & Virtual Patient Monitoring Platform, Covidien (2013) Summary page 5.
- K123002: Vital Sync System, Covidien, Formerly Nellcor Puritan Bennett, Inc. (2013) Summary page 5.
- K093422: Vital Sync Model 5000 Series, Somanetics Corp. (2010) Summary page 5.

## Most influential descendants
- K151715: T3 Software (2015), 17 descendants of its own
- K152258: T3 Software (2016), 16 descendants of its own
- K163065: T3 Software (2017), 15 descendants of its own
- K190273: T3 Platform software (2019), 14 descendants of its own
- K202306: T3 Platform software (2020), 13 descendants of its own

## Indications for use
The T3 Software is intended for the recording and display of multiple physiological parameters of adult, pediatric and neonatal patients from supported bedside devices. T3 is not intended for alarm notification or waveform display, nor is it intended to control any of the independent bedside devices to which it is connected. T3 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. T3 can display numeric physiologic data 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) WARNING: T3 Software is not an active patient monitoring system; it is intended to supplement and not replace any part of the hospital’s device monitoring. Do not rely on the T3 Software as the sole source of patient status information.

Source page: https://510kreport.com/device/K142732
Methodology: https://510kreport.com/methodology