510(k) · Cleared
ClearedEtiometry Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Etiometry, Inc. · PPW Adjunctive Cardiovascular Status Indicator
Cleared on Apr 3, 2026 as substantially equivalent to K241479 (Etiometry, Inc., 2025) after a 106-day review. Its family tree reaches back 15 generations to 1997.
- Decided
- Apr 3, 2026
- Review
- 106 days
- Class
- Class II
- Product code
- PPW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K962603 (1997). 60 ancestors in all, the oldest K891104 (1989). No later device cites it as a predicate yet.
- Root · 15 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 11 generations between
- 3 generations backK213230 T3 Platform SoftwareEtiometry, Inc. · 2022
- 2 generations backK213423 T3 Platform softwareEtiometry, Inc. · 2023
- 1 generation backK241479 Etiometry Platform (DAV 5.4 RAE 9.2)Etiometry, Inc. · 2025
- This deviceK254066 Etiometry PlatformEtiometry, Inc. · 2026
Show all 15 generations
- Root · 15 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 14 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 13 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 12 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 11 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 10 generations backK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- 9 generations backK081140 VisensiaObs Medical · 2008
- 8 generations backK110953 Visensia, Visensia with AlertObs Medical · 2011
- 7 generations backK152258 T3 SoftwareEtiometry, Inc. · 2016
- 6 generations backK163065 T3 SoftwareEtiometry, Inc. · 2017
- 5 generations backK190273 T3 Platform softwareEtiometry, Inc. · 2019
- 4 generations backK202306 T3 Platform softwareEtiometry, Inc. · 2020
- 3 generations backK213230 T3 Platform SoftwareEtiometry, Inc. · 2022
- 2 generations backK213423 T3 Platform softwareEtiometry, Inc. · 2023
- 1 generation backK241479 Etiometry Platform (DAV 5.4 RAE 9.2)Etiometry, Inc. · 2025
- This deviceK254066 Etiometry PlatformEtiometry, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −14 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −13 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −12 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −11 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −10 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| −9 | K081140 | Visensia | Obs Medical | 2008 | — |
| −8 | K110953 | Visensia, Visensia with Alert | Obs Medical | 2011 | — |
| −7 | K152258 | T3 Software | Etiometry, Inc. | 2016 | — |
| −6 | K163065 | T3 Software | Etiometry, Inc. | 2017 | — |
| −5 | K190273 | T3 Platform software | Etiometry, Inc. | 2019 | — |
| −4 | K202306 | T3 Platform software | Etiometry, Inc. | 2020 | — |
| −3 | K213230 | T3 Platform Software | Etiometry, Inc. | 2022 | — |
| −2 | K213423 | T3 Platform software | Etiometry, Inc. | 2023 | — |
| −1 | K241479 | Etiometry Platform (DAV 5.4 RAE 9.2) | Etiometry, Inc. | 2025 | — |
| 0 (this device) | 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 |
| 2023 | 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 PPW? 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 PPW device
- #1 K213230 T3 Platform Softwarescore 15.9 · 12 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 |
|---|---|---|---|
| * | K241479 | Etiometry Platform (DAV 5.4 RAE 9.2)Summary page 7…on Number 870.2200 Product Code(s) PPW 3. Legally Marketed Predicate Devices The predicate device is the platform version DAV 5.4 RAE 9.2, cleared under K241479, with the PPW product code. 4. Device Description Summary The Etiometry Platform allows ICU clinicians and quality improvement t… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 7 of the 60 ancestors have a recall of any class.
How does its category compare?
All PPW devicesPPW Adjunctive Cardiovascular Status Indicator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PPW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PPW
Too few PPW 510(k)s in any year since 2007 to give a median.
Recalls per year · PPW
No recall names PPW since 2007.
Adverse event reports per year · PPW
No MAUDE report names PPW 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 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Etiometry Platform TM software features the Data Aggregation & Visualization software module version 5.8 and the Risk Analytics Engine software module version 9.4. The Data Aggregation & Visualization software module is intended to record and display multiple physiological parameters of adult, pediatric, and neonatal patients from supported bedside devices. The software module is not intended for alarm notification, nor is it intended to control any…
Read the full statement (769 words)
The Etiometry Platform TM software features the Data Aggregation & Visualization software module version 5.8 and the Risk Analytics Engine software module version 9.4.
The Data Aggregation & Visualization software module is intended to record and display multiple physiological parameters of adult, pediatric, and neonatal patients from supported bedside devices. The software module is not intended for alarm notification, 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:
- 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.
The Data Aggregation & Visualization software module can display numeric physiologic data and waveforms 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)
- Electrocardiogram
- Plethysmograph
The Data Aggregation & Visualization software module can display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid.
The Data Aggregation & Visualization software module can display information captured by the Risk Analytics Engine software module.
The Risk Analytics Engine software module calculates four indices: the IDO2 Index™ for inadequate delivery of oxygen, the IVCO2 Index™ for inadequate ventilation of carbon dioxide, the ACD Index™ for acidemia, and the HLA Index™ for hyperlactatemia.
The IDO2 Index is indicated for use by health care professionals with post-surgical patients 0 to 12 years of age and weighing 2 kg or more under intensive care and patients 18 years of age or older under intensive care and not on Mechanical Circulatory Support. The IDO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the Data Aggregation & Visualization software module. When the 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 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.
The IVCO2 Index is indicated for use by healthcare professionals with invasively ventilated patients 0 to 12 years of age under intensive care. The IVCO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation and Visualization software module. When the IVCO2 Index is increasing, it means that there is an increasing risk of inadequate carbon dioxide ventilation, and attention should be brought to the patient. The IVCO2 Index™ presents partial quantitative information about the patient's respiratory condition, and no therapy or drugs can be administered based solely on the interpretation statements.
The ACD Index is indicated for use by health care professionals with invasively ventilated patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The ACD Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the Data Aggregation and Visualization software module. When the ACD Index is increasing, it means that there is an increasing risk of acidemia, and attention should be brought to the patient. The ACD Index presents partial quantitative information about the patient's respiratory condition, and no therapy or drugs can be administered based solely on the interpretation statements.
The HLA Index is indicated for use by health care professionals with post-surgical patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The HLA Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the Data Aggregation & Visualization software module. When the HLA Index is increasing, it means that there is an increasing risk of hyperlactatemia, and attention should be brought to the patient. The HLA 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 as stated in the FDA summary.
https://510kreport.com/device/K254066 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254066: Etiometry Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254066
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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