510(k) · Cleared
ClearedT3 Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Etiometry, Inc. · PLB Multivariate Vital Signs Index
Cleared on Mar 31, 2016 as substantially equivalent to K142732 (Etiometry, Inc., 2015) and 3 other predicates after a 233-day review. Its family tree reaches back 8 generations to 1997. 16 later devices descend from it.
- Decided
- Mar 31, 2016
- Review
- 233 days
- Class
- Class II
- Product code
- PLB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K962603 (1997). 51 ancestors in all, the oldest K891104 (1989). 16 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 7 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 6 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 5 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 4 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 3 generations backK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- 2 generations backK081140 VisensiaObs Medical · 2008
- 1 generation backK110953 Visensia, Visensia with AlertObs Medical · 2011
- This deviceK152258 T3 SoftwareEtiometry, Inc. · 2016
- Descendant · cites it directly · 15 of its ownK163065 T3 SoftwareEtiometry, Inc. · 2017
- Descendant · 2 generations on · 14 of its ownK190273 T3 Platform softwareEtiometry, Inc. · 2019
- Descendant · 3 generations on · 13 of its ownK202306 T3 Platform softwareEtiometry, Inc. · 2020
- Descendant · 4 generations on · 12 of its ownK213230 T3 Platform SoftwareEtiometry, Inc. · 2022
- Descendant · 5 generations on · 7 of its ownK222463 EchoGo Heart FailureUltromics Limited · 2022
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K163065T3 SoftwareEtiometry, Inc. · 2017 · cites it directly15descendants
- K190273T3 Platform softwareEtiometry, Inc. · 2019 · 2 generations on14descendants
- K202306T3 Platform softwareEtiometry, Inc. · 2020 · 3 generations on13descendants
- K213230T3 Platform SoftwareEtiometry, Inc. · 2022 · 4 generations on12descendants
- K222463EchoGo Heart FailureUltromics Limited · 2022 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −7 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −6 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −5 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −4 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −3 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| −2 | K081140 | Visensia | Obs Medical | 2008 | — |
| −1 | K110953 | Visensia, Visensia with Alert | Obs Medical | 2011 | — |
| 0 (this device) | K152258 | T3 Software | Etiometry, Inc. | 2016 | — |
| +1 | K163065 | T3 Software | Etiometry, Inc. | 2017 | — |
| +2 | K190273 | T3 Platform software | Etiometry, Inc. | 2019 | — |
| +3 | K202306 | T3 Platform software | Etiometry, Inc. | 2020 | — |
| +4 | K213230 | T3 Platform Software | Etiometry, Inc. | 2022 | — |
| +5 | K222463 | EchoGo Heart Failure | Ultromics Limited | 2022 | — |
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 |
|---|---|---|
| 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 PLB? 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 PLB device
- #1 K240756 Aitrics-VCscore 16.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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…ode is MWI; monitor, physiological, patient (without arrhythmia detection or alarms) III. Predicate Device 1. T3 Software (Version 1.9) cleared under K142732 and K151715. 2. Visensia cleared under K081140 and K110953. Page 1 of 4… | 2015 |
| * | K151715 | T3 Software Cleared while this submission was under review Summary page 5…monitor, physiological, patient (without arrhythmia detection or alarms) III. Predicate Device 1. T3 Software (Version 1.9) cleared under K142732 and K151715. 2. Visensia cleared under K081140 and K110953. Page 1 of 4 === Page 6… | 2015 |
| * | K081140 | VisensiaSummary page 5…arrhythmia detection or alarms) III. Predicate Device 1. T3 Software (Version 1.9) cleared under K142732 and K151715. 2. Visensia cleared under K081140 and K110953. Page 1 of 4 IV. Device Description The Tracking,… | 2008 |
| * | K110953 | Visensia, Visensia with AlertSummary page 5…etection or alarms) III. Predicate Device 1. T3 Software (Version 1.9) cleared under K142732 and K151715. 2. Visensia cleared under K081140 and K110953. Page 1 of 4 IV. Device Description The Tracking, Trajectory,… | 2011 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163065 | T3 Software | 2017 | 15 |
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 19 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 7 of the 51 ancestors have a recall of any class.
- Of its descendants, K163065 (Etiometry, Inc., 2017) has gone furthest, with 15 descendants of its own.
- 1 other device also cites its predicate K142732.
How does its category compare?
All PLB devicesPLB Multivariate Vital Signs Index: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PLB
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PLB
Too few PLB 510(k)s in any year since 2007 to give a median.
Recalls per year · PLB
No recall names PLB since 2007.
Adverse event reports per year · PLB
No MAUDE report names PLB since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
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 (387 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 post-surgical neonatal patients 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.
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/K152258 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152258: 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/K152258
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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