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 Oct 29, 2015 as substantially equivalent to K142732 (Etiometry, Inc., 2015) after a 126-day review. Its family tree reaches back 6 generations to 2000. 17 later devices descend from it.
- Decided
- Oct 29, 2015
- Review
- 126 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K991684 (2000). 14 ancestors in all. 17 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK991684 Chillbuster Portable Electric Blanket System, Model 8001Thermogear, Inc. · 2000
- 5 generations backK022903 ChillbusterMicrotek Medical, Inc. · 2002
- 4 generations backK052392 Hot Dog Patient Warming SystemAugustine Biomedical & Design, LLC · 2006
- 3 generations backK093244 Unique Temp Warming Blankets, Model 8001140XXXGeratherm Medical AG · 2010
- 2 generations backK123002 Vital Sync SystemCovidien, Formerly Nellcor Puritan Bennett, Inc. · 2013
- 1 generation backK142732 T3 SoftwareEtiometry, Inc. · 2015
- This deviceK151715 T3 SoftwareEtiometry, Inc. · 2015
- Descendant · cites it directly · 16 of its ownK152258 T3 SoftwareEtiometry, Inc. · 2016
- Descendant · 2 generations on · 15 of its ownK163065 T3 SoftwareEtiometry, Inc. · 2017
- Descendant · 3 generations on · 14 of its ownK190273 T3 Platform softwareEtiometry, Inc. · 2019
- Descendant · 4 generations on · 13 of its ownK202306 T3 Platform softwareEtiometry, Inc. · 2020
- Descendant · 5 generations on · 12 of its ownK213230 T3 Platform SoftwareEtiometry, Inc. · 2022
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K152258T3 SoftwareEtiometry, Inc. · 2016 · cites it directly16descendants
- K163065T3 SoftwareEtiometry, Inc. · 2017 · 2 generations on15descendants
- K190273T3 Platform softwareEtiometry, Inc. · 2019 · 3 generations on14descendants
- K202306T3 Platform softwareEtiometry, Inc. · 2020 · 4 generations on13descendants
- K213230T3 Platform SoftwareEtiometry, Inc. · 2022 · 5 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K991684 | Chillbuster Portable Electric Blanket System, Model 8001 | Thermogear, Inc. | 2000 | — |
| −5 | K022903 | Chillbuster | Microtek Medical, Inc. | 2002 | — |
| −4 | K052392 | Hot Dog Patient Warming System | Augustine Biomedical & Design, LLC | 2006 | — |
| −3 | K093244 | Unique Temp Warming Blankets, Model 8001140XXX | Geratherm Medical AG | 2010 | — |
| −2 | K123002 | Vital Sync System | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2013 | — |
| −1 | K142732 | T3 Software | Etiometry, Inc. | 2015 | — |
| 0 (this device) | K151715 | T3 Software | Etiometry, Inc. | 2015 | — |
| +1 | K152258 | T3 Software | Etiometry, Inc. | 2016 | — |
| +2 | K163065 | T3 Software | Etiometry, Inc. | 2017 | — |
| +3 | K190273 | T3 Platform software | Etiometry, Inc. | 2019 | — |
| +4 | K202306 | T3 Platform software | Etiometry, Inc. | 2020 | — |
| +5 | K213230 | T3 Platform Software | Etiometry, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K142732 | T3 SoftwareSummary page 5…; monitor, physiological, patient (without arrhythmia detection or alarms) III. Predicate Device T3 Software (Version 1.8), cleared under K142732. Page 1 of 5 K151715 Etiometry… | 2015 |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152258 | T3 Software | 2016 | 16 |
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 15 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- 4 of the 14 ancestors have a recall of any class.
- Of its descendants, K152258 (Etiometry, Inc., 2016) has gone furthest, with 16 descendants of its own.
- 1 other device also cites its predicate K142732.
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. 2015, 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…
Read the full statement (281 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.
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 Solution as the sole source of patient status information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151715 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151715: T3 Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151715
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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