510(k) · Cleared
ClearedT3 Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Etiometry, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on May 26, 2017 as substantially equivalent to K152258 (Etiometry, Inc., 2016) after a 205-day review. Its family tree reaches back 9 generations to 1997. 15 later devices descend from it.
- Decided
- May 26, 2017
- Review
- 205 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K962603 (1997). 52 ancestors in all, the oldest K891104 (1989). 15 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations between
- 3 generations backK081140 VisensiaObs Medical · 2008
- 2 generations backK110953 Visensia, Visensia with AlertObs Medical · 2011
- 1 generation backK152258 T3 SoftwareEtiometry, Inc. · 2016
- This deviceK163065 T3 SoftwareEtiometry, Inc. · 2017
- Descendant · cites it directly · 14 of its ownK190273 T3 Platform softwareEtiometry, Inc. · 2019
- Descendant · 2 generations on · 13 of its ownK202306 T3 Platform softwareEtiometry, Inc. · 2020
- Descendant · 3 generations on · 12 of its ownK213230 T3 Platform SoftwareEtiometry, Inc. · 2022
- Descendant · 4 generations on · 7 of its ownK222463 EchoGo Heart FailureUltromics Limited · 2022
- Descendant · 5 generations on · 2 of its ownK240860 EchoGo Amyloidosis (1.0)Ultromics Limited · 2024
Show all 9 generations
- Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 8 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 7 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 6 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 5 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 4 generations backK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- 3 generations backK081140 VisensiaObs Medical · 2008
- 2 generations backK110953 Visensia, Visensia with AlertObs Medical · 2011
- 1 generation backK152258 T3 SoftwareEtiometry, Inc. · 2016
- This deviceK163065 T3 SoftwareEtiometry, Inc. · 2017
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K190273T3 Platform softwareEtiometry, Inc. · 2019 · cites it directly14descendants
- K202306T3 Platform softwareEtiometry, Inc. · 2020 · 2 generations on13descendants
- K213230T3 Platform SoftwareEtiometry, Inc. · 2022 · 3 generations on12descendants
- K222463EchoGo Heart FailureUltromics Limited · 2022 · 4 generations on7descendants
- K240860EchoGo Amyloidosis (1.0)Ultromics Limited · 2024 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −8 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −7 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −6 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −5 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −4 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| −3 | K081140 | Visensia | Obs Medical | 2008 | — |
| −2 | K110953 | Visensia, Visensia with Alert | Obs Medical | 2011 | — |
| −1 | K152258 | T3 Software | Etiometry, Inc. | 2016 | — |
| 0 (this device) | K163065 | T3 Software | Etiometry, Inc. | 2017 | — |
| +1 | K190273 | T3 Platform software | Etiometry, Inc. | 2019 | — |
| +2 | K202306 | T3 Platform software | Etiometry, Inc. | 2020 | — |
| +3 | K213230 | T3 Platform Software | Etiometry, Inc. | 2022 | — |
| +4 | K222463 | EchoGo Heart Failure | Ultromics Limited | 2022 | — |
| +5 | K240860 | EchoGo Amyloidosis (1.0) | Ultromics Limited | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MWI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K152258 | T3 SoftwareSummary page 5…ation of a summary index (or indices) based on several individual measured vital sign inputs. III. Predicate Device T3 Software (Version 2.0) cleared under K152258 IV. Device Description The Tracking, Trajectory, Trigger (T3) intensive care unit software solution allows clinicia… | 2016 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190273 | T3 Platform software | 2019 | 14 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 7 of the 52 ancestors have a recall of any class.
- Of its descendants, K190273 (Etiometry, Inc., 2019) has gone furthest, with 14 descendants of its own.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
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…
Read the full statement (415 words)
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.
T3 includes a Patient Risk Analytics Engine that calculates an index (the Inadequate Oxygen Delivery Index) that is indicated for use by health care professionals with postsurgical patients aged zero days to twelve years weighing 2 kg or more under intensive care. The Inadequate Oxygen Delivery Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by T3. When the index is elevated, it means that there is increased risk of inadequate oxygen delivery and attention should be brought to the patient. The 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.
WARNINGS:
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 Solution as the sole source of patient status information.
The scale for the Inadequate Oxygen Delivery Index (IDO2) is the opposite of the scale for oxygen saturation measurements such as those provided by pulse oximetry. A high value for IDO2 indicates increased risk of inadequate oxygen delivery. A low value indicates reduced risk or normality.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K163065 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163065: T3 Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163065
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026