510(k) · Cleared
ClearedEV1000 Clinical Platform NI, EV1000 Clinical Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Aug 30, 2019 as substantially equivalent to K160552 (Edwards Lifesciences, LLC, 2016) and 1 other predicate after a 29-day review. Its family tree reaches back 11 generations to 2000. 1 of the 28 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 30, 2019
- Review
- 29 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K000126 (2000). 27 ancestors in all, the oldest K822055 (1982). No later device cites it as a predicate yet. 1 of the 28 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK000126 Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp. · 2000
- 7 generations between
- 3 generations backK122381 Nexfin Model 2Edwards Lifesciences, LLC · 2013
- 2 generations backK140312 EV1000 Clinical Platform with Clearsight TM Finger Cuff or…Edwards Lifesciences, LLC · 2014 · Recalled
- 1 generation backK160552 EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight…Edwards Lifesciences, LLC · 2016 · Recalled (Class I)
- This deviceK192058 EV1000 Clinical Platform NI, EV1000 Clinical PlatformEdwards Lifesciences, LLC · 2019
Show all 11 generations
- Root · 11 generations backK000126 Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp. · 2000
- 10 generations backK031330 Modification to Masimo Set Radical Pulse Oximeter with Satshare and…Masimo Corp. · 2003
- 9 generations backK033296 Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V…Masimo Corp. · 2004 · Recalled
- 8 generations backK042536 Masimo Set Rad 57 Pulse CO-OximeterMasimo Corporation · 2005 · Recalled
- 7 generations backK053477 Masimo Set Rad 57 CM and M Pulse CO-OximetersMasimo Corporation · 2006
- 6 generations backK061204 Masimo Set Radical 7 Pulse CO-OximeterMasimo Corporation · 2006
- 5 generations backK080238 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set…Masimo Corporation · 2008 · Recalled
- 4 generations backK101123 Nexfin Model 2Bmeye B.V. · 2010
- 3 generations backK122381 Nexfin Model 2Edwards Lifesciences, LLC · 2013
- 2 generations backK140312 EV1000 Clinical Platform with Clearsight TM Finger Cuff or…Edwards Lifesciences, LLC · 2014 · Recalled
- 1 generation backK160552 EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight…Edwards Lifesciences, LLC · 2016 · Recalled (Class I)
- This deviceK192058 EV1000 Clinical Platform NI, EV1000 Clinical PlatformEdwards Lifesciences, LLC · 2019
Class I recalls in this family
- K160552 EV1000 Clinical Platform with ClearSight Finger…direct predicate · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K000126 | Masimo Set Radical Pulse Oximeter with Satshare, Masimo… | Masimo Corp. | 2000 | — |
| −10 | K031330 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop… | Masimo Corp. | 2003 | — |
| −9 | K033296 | Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse… | Masimo Corp. | 2004 | 1 |
| −8 | K042536 | Masimo Set Rad 57 Pulse CO-Oximeter | Masimo Corporation | 2005 | 1 |
| −7 | K053477 | Masimo Set Rad 57 CM and M Pulse CO-Oximeters | Masimo Corporation | 2006 | — |
| −6 | K061204 | Masimo Set Radical 7 Pulse CO-Oximeter | Masimo Corporation | 2006 | — |
| −5 | K080238 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87… | Masimo Corporation | 2008 | 1 |
| −4 | K101123 | Nexfin Model 2 | Bmeye B.V. | 2010 | — |
| −3 | K122381 | Nexfin Model 2 | Edwards Lifesciences, LLC | 2013 | — |
| −2 | K140312 | EV1000 Clinical Platform with Clearsight TM Finger Cuff or Clearsight TM System | Edwards Lifesciences, LLC | 2014 | 1 |
| −1 | K160552 | EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System… | Edwards Lifesciences, LLC | 2016 | Class I |
| 0 (this device) | K192058 | EV1000 Clinical Platform NI, EV1000 Clinical Platform | Edwards Lifesciences, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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.
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 DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K160552 | EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000…Summary page 4…(21 CFR 870.1130) Regulation Class / Class II Class II Product Code DXG, DXN DXG K160552 – EV1000 Clinical Primary Predicate Platform™ NI with ClearSight™ K160552 – EV1000 Clinical Device(s) Finger Cuff… | 2016 |
| * | K183646 | Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension…Summary page 4…Finger Cuffs or ClearSight Platform™ (cleared 06/01/2016) System (cleared 06/01/2016) K183646 - Acumen Hypotension Secondary Not applicable Prediction Index – EV1000 Clinical Device… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 6 of the 27 ancestors have a recall of any class; 1 has a Class I recall.
- 8 other devices also cite its predicate K160552.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, 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 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
EV1000 Clinical Platform (EV1000A): 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. The EV1000 Clinical Platform may be used for the monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol. Analysis of the thermodilution curve in terms of…
Read the full statement (306 words)
EV1000 Clinical Platform (EV1000A):
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. The EV1000 Clinical Platform
may be used for the monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy
protocol. 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.
The Edwards Lifesciences Acumen Hypotension Prediction Index feature provides the clinician with physiological insight
into a patient’s likelihood of future hypotensive events (defined as mean arterial pressure < 65 mmHg for at least one
minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical or
nonsurgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be
additional quantitative information regarding the patient’s physiological condition for reference only and no therapeutic
decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter.
EV1000 Clinical Platform NI (EV1000NI):
The EV1000 Clinical Platform NI and the ClearSight Finger Cuffs are indicated for patients over 18 years of age in which
the balance between cardiac function, fluid status, and vascular resistance needs continuous assessment. The EV1000
Clinical Platform may be used for the monitoring of hemodynamic parameters in conjunction with a perioperative goal
directed therapy protocol. In addition, the non-invasive system is indicated for use in patients with co- morbidities for
which hemodynamic optimization is desired and invasive measurements are difficult. The EV1000 Clinical Platform and
the ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192058 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192058: EV1000 Clinical Platform NI, 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/K192058
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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