510(k) · Cleared
ClearedT3 Platform 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 Jan 6, 2023 as substantially equivalent to K213230 (Etiometry, Inc., 2022) after a 443-day review. Its family tree reaches back 13 generations to 1997. 2 later devices descend from it.
- Decided
- Jan 6, 2023
- Review
- 443 days
- Class
- Class II
- Product code
- PLB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K962603 (1997). 57 ancestors in all, the oldest K891104 (1989). 2 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 9 generations between
- 3 generations backK190273 T3 Platform softwareEtiometry, Inc. · 2019
- 2 generations backK202306 T3 Platform softwareEtiometry, Inc. · 2020
- 1 generation backK213230 T3 Platform SoftwareEtiometry, Inc. · 2022
- This deviceK213423 T3 Platform softwareEtiometry, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK241479 Etiometry Platform (DAV 5.4 RAE 9.2)Etiometry, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK254066 Etiometry PlatformEtiometry, Inc. · 2026
Show all 13 generations
- Root · 13 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 12 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 11 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 10 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 9 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 8 generations backK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- 7 generations backK081140 VisensiaObs Medical · 2008
- 6 generations backK110953 Visensia, Visensia with AlertObs Medical · 2011
- 5 generations backK152258 T3 SoftwareEtiometry, Inc. · 2016
- 4 generations backK163065 T3 SoftwareEtiometry, Inc. · 2017
- 3 generations backK190273 T3 Platform softwareEtiometry, Inc. · 2019
- 2 generations backK202306 T3 Platform softwareEtiometry, Inc. · 2020
- 1 generation backK213230 T3 Platform SoftwareEtiometry, Inc. · 2022
- This deviceK213423 T3 Platform softwareEtiometry, Inc. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −12 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −11 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −10 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −9 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −8 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| −7 | K081140 | Visensia | Obs Medical | 2008 | — |
| −6 | K110953 | Visensia, Visensia with Alert | Obs Medical | 2011 | — |
| −5 | K152258 | T3 Software | Etiometry, Inc. | 2016 | — |
| −4 | K163065 | T3 Software | Etiometry, Inc. | 2017 | — |
| −3 | K190273 | T3 Platform software | Etiometry, Inc. | 2019 | — |
| −2 | K202306 | T3 Platform software | Etiometry, Inc. | 2020 | — |
| −1 | K213230 | T3 Platform Software | Etiometry, Inc. | 2022 | — |
| 0 (this device) | K213423 | T3 Platform software | Etiometry, Inc. | 2023 | — |
| +1 | K241479 | Etiometry Platform (DAV 5.4 RAE 9.2) | Etiometry, Inc. | 2025 | — |
| +2 | K254066 | Etiometry Platform | Etiometry, Inc. | 2026 | — |
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 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 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? (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 |
|---|---|---|---|
| * | K213230 | T3 Platform Software Cleared while this submission was under review Summary page 8…T3 Risk Analytics Engine software module version 8.0 cleared under K213230. The Risk Analytics Engine module was modified to become the Adult Risk Analy… | 2022 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241479 | Etiometry Platform (DAV 5.4 RAE 9.2) | 2025 | 1 |
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 26 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 7 of the 57 ancestors have a recall of any class.
- Of its descendants, K241479 (Etiometry, Inc., 2025) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K213230.
How does its category compare?
All PLB devicesPLB Multivariate Vital Signs Index: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Platform™ software features the T3 Data Aggregation & Visualization software module version 5.0 and the T3 Adult Risk Analytics Engine software module version 1.0. The T3 Data Aggregation & Visualization software module is intended for the recording and display of multiple physiological parameters of the adult, pediatric, and neonatal patients from supported bedside devices. The software module is not intended for alarm notification or waveform…
Read the full statement (417 words)
The T3 Platform™ software features the T3 Data Aggregation & Visualization software module version 5.0 and the T3 Adult Risk Analytics Engine software module version 1.0.
The T3 Data Aggregation & Visualization software module is intended for the recording and display of multiple physiological parameters of the adult, pediatric, and neonatal patients from supported bedside devices. The software module 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. The software module is intended to be used by healthcare professionals for the following purposes:
e To remotely consult regarding a patient’s status, and
e 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.
The T3 Data Aggregation & Visualization software module 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)
The T3 Data Aggregation & Visualization software module can display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid.
The T3 Data Aggregation & Visualization software module can display information captured by the T3 Adult Risk Analytics Engine software module.
The T3 Adult Risk Analytics Engine software module calculates the Adult IDO2 Index for inadequate delivery of oxygen. The Adult IDO2 Index is indicated for use by health care professionals with post-surgical patients 18 years of age or older under intensive care and not on Mechanical Circulatory Support. The Adult IDO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation & Visualization software module. When the Adult IDO2 Index is increasing, it means that there is an increasing risk of inadequate oxygen delivery and attention should be brought to the patient. The Adult IDO2 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.
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/K213423 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213423: T3 Platform software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213423
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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