510(k) · Cleared
ClearedEV1000 Clinical Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Cleared on May 22, 2014 as substantially equivalent to K110597 (Edwards Lifesciences, 2011) after a 331-day review. Its family tree reaches back 4 generations to 2006. 1 of the 58 devices in its family, counting itself, has a Class I recall. 52 later devices descend from it.
- Decided
- May 22, 2014
- Review
- 331 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K062134 (2006). 5 ancestors in all. 52 later devices descend from it, 1 citing it directly. 1 of the 58 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK062134 Vigileo Arterial Pressure Cardiac Output/Oximetry MonitorEdwards Lifesciences, LLC · 2006
- 3 generations backK082308 Modification to Vigileo Arterial Pressure Cardiac Output/Oximetry…Edwards Lifesciences, LLC · 2008
- 2 generations backK100709 EV1000 Platform Model: EV1000A, EV1000DB, EV1000MEdwards Lifesciences, LLC · 2010
- 1 generation backK110597 EV1000 Clinical PlatformEdwards Lifesciences · 2011
- This deviceK131892 EV1000 Clinical PlatformEdwards Lifesciences, LLC · 2014
- Descendant · cites it directly · 51 of its ownK160552 EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight…Edwards Lifesciences, LLC · 2016 · Recalled (Class I)
- Descendant · 2 generations on · 41 of its ownK163381 HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere…Edwards Lifesciences, LLC · 2017 · Recalled
- Descendant · 2 generations on · 40 of its ownK180881 HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC · 2018
- Descendant · 3 generations on · 34 of its ownK190205 HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC · 2019
- Descendant · 2 generations on · 30 of its ownK182245 EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger…Edwards Lifesciences, LLC · 2018
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K160552 EV1000 Clinical Platform with ClearSight Finger…cites it directly · 2016
Most influential descendants
Showing 5 of 52 · See all- K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000…Edwards Lifesciences, LLC · 2016 · cites it directly51descendants
- K163381HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry CableEdwards Lifesciences, LLC · 2017 · 2 generations on41descendants
- K180881HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC · 2018 · 2 generations on40descendants
- K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC · 2019 · 3 generations on34descendants
- K182245EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight…Edwards Lifesciences, LLC · 2018 · 2 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K062134 | Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor | Edwards Lifesciences, LLC | 2006 | — |
| −3 | K082308 | Modification to Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor | Edwards Lifesciences, LLC | 2008 | — |
| −2 | K100709 | EV1000 Platform Model: EV1000A, EV1000DB, EV1000M | Edwards Lifesciences, LLC | 2010 | — |
| −1 | K110597 | EV1000 Clinical Platform | Edwards Lifesciences | 2011 | — |
| 0 (this device) | K131892 | EV1000 Clinical Platform | Edwards Lifesciences, LLC | 2014 | — |
| +1 | K160552 | EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System… | Edwards Lifesciences, LLC | 2016 | Class I |
| +2 | K163381 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry… | Edwards Lifesciences, LLC | 2017 | 2 |
| +2 | K180881 | HemoSphere Advanced Monitor, HemoSphere Pressure Cable | Edwards Lifesciences, LLC | 2018 | — |
| +3 | K190205 | HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module | Edwards Lifesciences, LLC | 2019 | — |
| +2 | K182245 | EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or… | Edwards Lifesciences, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 1 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 6 | 0 |
| 2020 | 1 | 0 |
| 2021 | 7 | 0 |
| 2022 | 6 | 0 |
| 2023 | 11 | 0 |
| 2024 | 5 | 0 |
| 2025 | 8 | 0 |
| 2026 | 4 | 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.
1 device in this family has a Class I recall. 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 DXG device
- #1 K253092 Argos Infinity (Rev. 1.0)score 11.1 · 2 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 |
|---|---|---|---|
| * | K110597 | EV1000 Clinical PlatformSummary page 1…Name (21 CER 870.1435, product code DXG) Regulation Class Il/ Class/ Product DXG, DQE Code Predicate Device EV 1000 Clinical Platform, KI 110597 (cleared 14 June 2011) The EV1000 Clinical Platform consists of Databox and Monitor Device compone… | 2011 |
What descends from it? (52)
See all 521 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160552 | EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000… Class I | 2016 | 51 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC · 2016 · Cites it directly · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K160552 (Edwards Lifesciences, LLC, 2016) has gone furthest, with 51 descendants of its own.
- 1 other device also cites its predicate K110597.
How does its category compare?
All DXG devicesDXG Computer, Diagnostic, Pre-Programmed, Single-Function: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DXG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXG
290in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXG
8in 2025
MAUDE reports naming product code DXG, 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 | 1 | — | 1 | 43 |
| 2008 | 5 | 118 | 1 | 37 |
| 2009 | 0 | — | 6 | 8 |
| 2010 | 4 | 282 | 1 | 17 |
| 2011 | 3 | 104 | 0 | 7 |
| 2012 | 2 | — | 0 | 29 |
| 2013 | 3 | 236 | 0 | 23 |
| 2014 | 6 | 290 | 0 | 44 |
| 2015 | 1 | — | 0 | 34 |
| 2016 | 1 | — | 0 | 67 |
| 2017 | 1 | — | 0 | 62 |
| 2018 | 2 | — | 0 | 83 |
| 2019 | 2 | — | 0 | 81 |
| 2020 | 1 | — | 2 | 49 |
| 2021 | 1 | — | 0 | 29 |
| 2022 | 0 | — | 0 | 44 |
| 2023 | 1 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 21 |
| 2025 | 1 | — | 0 | 8 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The EV1000 Clinical Platform is indicated for use primarily for critical care patients in which the balance between cardiac function, fluid status and vascular resistance needs continuous or intermittent assessment. Analysis of the thermodilution curve in terms of mean transit time and the shape is used to determine intravascular and extravascular fluid volumes. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics. The EV1000 Clinical Platform may be used in all settings in which critical care is provided.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131892 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131892: EV1000 Clinical Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131892
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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