FDA 510(k) · Etiometry
K152258: T3 Software (Etiometry, Inc.)
Etiometry, Inc. received FDA 510(k) K152258 for T3 Software, with a decision date of Mar 31, 2016 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K152258 |
|---|---|
| Pathway | 510(k) |
| Applicant | Etiometry, Inc. |
| Device name | T3 Software |
| Product code | PLB: Multivariate Vital Signs Index |
| Regulation (21 CFR) | 870.2300 |
| Device class | Class 2 |
| Date received | Aug 11, 2015 |
| Decision date | Mar 31, 2016 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
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) It can also display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid. 7LQFOXGHVD3DWLHQW5LVN$QDO\WLFV(QJLQHWKDWFDOFXODWHVDQLQGH[ WKH,QDGHTXDWH2[\JHQ'HOLYHU\,QGH[ WKDWLV LQGLFDWHGIRUXVHE\KHDOWKFDUHSURIHVVLRQDOVZLWKSRVWVXUJLFDOQHRQDWDOSDWL
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code PLB is "Multivariate Vital Signs Index", class 2, 21 CFR 870.2300. FDA's definition: "Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs."
Our labels for filtering: claim Remote / vital-sign monitoring, sensor Unknown. These are heuristics, not FDA fields.