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 · DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Cleared on Jun 14, 2011 as substantially equivalent to K100709 (Edwards Lifesciences, LLC, 2010) and 2 other predicates after a 104-day review. Its family tree reaches back 3 generations to 2006. 1 of the 59 devices in its family, counting itself, has a Class I recall. 54 later devices descend from it.
- Decided
- Jun 14, 2011
- Review
- 104 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K062134 (2006). 4 ancestors in all. 54 later devices descend from it, 2 citing it directly. 1 of the 59 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK062134 Vigileo Arterial Pressure Cardiac Output/Oximetry MonitorEdwards Lifesciences, LLC · 2006
- 2 generations backK082308 Modification to Vigileo Arterial Pressure Cardiac Output/Oximetry…Edwards Lifesciences, LLC · 2008
- 1 generation backK100709 EV1000 Platform Model: EV1000A, EV1000DB, EV1000MEdwards Lifesciences, LLC · 2010
- This deviceK110597 EV1000 Clinical PlatformEdwards Lifesciences · 2011
- Descendant · cites it directly · 52 of its ownK140312 EV1000 Clinical Platform with Clearsight TM Finger Cuff or…Edwards Lifesciences, LLC · 2014 · Recalled
- Descendant · cites it directly · 52 of its ownK131892 EV1000 Clinical PlatformEdwards Lifesciences, LLC · 2014
- Descendant · 2 generations on · 51 of its ownK160552 EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight…Edwards Lifesciences, LLC · 2016 · Recalled (Class I)
- Descendant · 3 generations on · 41 of its ownK163381 HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere…Edwards Lifesciences, LLC · 2017 · Recalled
- Descendant · 3 generations on · 40 of its ownK180881 HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC · 2018
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K160552 EV1000 Clinical Platform with ClearSight Finger…2 generations on · 2016
Most influential descendants
Showing 5 of 54 · See all- K140312EV1000 Clinical Platform with Clearsight TM Finger Cuff or Clearsight TM SystemEdwards Lifesciences, LLC · 2014 · cites it directly52descendants
- K131892EV1000 Clinical PlatformEdwards Lifesciences, LLC · 2014 · cites it directly52descendants
- K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000…Edwards Lifesciences, LLC · 2016 · 2 generations on51descendants
- K163381HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry CableEdwards Lifesciences, LLC · 2017 · 3 generations on41descendants
- K180881HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC · 2018 · 3 generations on40descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K062134 | Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor | Edwards Lifesciences, LLC | 2006 | — |
| −2 | K082308 | Modification to Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor | Edwards Lifesciences, LLC | 2008 | — |
| −1 | K100709 | EV1000 Platform Model: EV1000A, EV1000DB, EV1000M | Edwards Lifesciences, LLC | 2010 | — |
| 0 (this device) | K110597 | EV1000 Clinical Platform | Edwards Lifesciences | 2011 | — |
| +1 | K140312 | EV1000 Clinical Platform with Clearsight TM Finger Cuff or Clearsight TM System | Edwards Lifesciences, LLC | 2014 | 1 |
| +1 | K131892 | EV1000 Clinical Platform | Edwards Lifesciences, LLC | 2014 | — |
| +2 | K160552 | EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System… | Edwards Lifesciences, LLC | 2016 | Class I |
| +3 | K163381 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry… | Edwards Lifesciences, LLC | 2017 | 2 |
| +3 | K180881 | HemoSphere Advanced Monitor, HemoSphere Pressure Cable | 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 |
|---|---|---|
| 2014 | 2 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K100709 | EV1000 Platform Model: EV1000A, EV1000DB, EV1000MSummary page 1…e: EVIOOO0 Clinical Platform Classification Single-Function, Preprogrammed Diagnostic Computer Name: (21 CFR 870.1435) Predicate 9 K 100709, Edwards Lifesciences LLC, EV 1000 Platform Devices: * K0823 08, Edwards. Lifesciences LLC, Vigileo Arterial… | 2010 |
| * | K082308 | Modification to Vigileo Arterial Pressure Cardiac Output/Oximetry MonitorSummary page 1…programmed Diagnostic Computer Name: (21 CFR 870.1435) Predicate 9 K 100709, Edwards Lifesciences LLC, EV 1000 Platform Devices: * K0823 08, Edwards. Lifesciences LLC, Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor… | 2008 |
| * | K072735 | Pulsion Picco-2, Model 8500Summary page 1…rm Devices: * K0823 08, Edwards. Lifesciences LLC, Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor * K072735, Pulsion Medical Systems, PiCCO-2 Device The EVlOOO0 Clinical Platform consists of a Databox and Description:… | 2007 |
What descends from it? (54)
See all 542 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 2 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K140312 (Edwards Lifesciences, LLC, 2014) has gone furthest, with 52 descendants of its own.
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. 2011, 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 EV 1000 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/K110597 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110597: 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/K110597
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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