510(k) · Cleared
ClearedHemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · DQK Computer, Diagnostic, Programmable
Cleared on May 28, 2021 as substantially equivalent to K201446 (Edwards Lifesiences, LLC, 2020) and 2 other predicates after a 162-day review. Its family tree reaches back 27 generations to 1994. 1 of the 261 devices in its family, counting itself, has a Class I recall. 18 later devices descend from it.
- Decided
- May 28, 2021
- Review
- 162 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 27 generations to K941811 (1994). 242 ancestors in all, the oldest K822055 (1982). 18 later devices descend from it, 4 citing it directly. 1 of the 261 devices in this family, counting this one, has a Class I recall.
- Root · 27 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 23 generations between
- 3 generations backK180881 HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC · 2018
- 2 generations backK190205 HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC · 2019
- 1 generation backK201446 HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC · 2020 · Recalled
- This deviceK203687 HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen…Edwards Lifesciences, LLC · 2021
- Descendant · cites it directly · 14 of its ownK213682 HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere…Edwards Lifesciences, LLC · 2022
- Descendant · 2 generations on · 7 of its ownK223865 HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen…Edwards Lifesciences, LLC · 2023
- Descendant · cites it directly · 6 of its ownK231038 Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC · 2023
- Descendant · 2 generations on · 6 of its ownK223651 Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC · 2023
- Descendant · cites it directly · 6 of its ownK221704 HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP)…Edwards Lifesciences, LLC · 2022
Show all 27 generations
- Root · 27 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 26 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 25 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 24 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 23 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 22 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 21 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 20 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 19 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 18 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 17 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 16 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 15 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
- 14 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
- 13 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
- 12 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
- 11 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
- 10 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
- 9 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
- 8 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
- 7 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
- 6 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
- 5 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
- 4 generations backK062283 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90…Philips Medical Systems North America, Inc. · 2006
- 3 generations backK180881 HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC · 2018
- 2 generations backK190205 HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC · 2019
- 1 generation backK201446 HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC · 2020 · Recalled
- This deviceK203687 HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen…Edwards Lifesciences, LLC · 2021
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K160552 EV1000 Clinical Platform with ClearSight Finger…2 generations back · 2016
Most influential descendants
Showing 5 of 18 · See all- K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC · 2022 · cites it directly14descendants
- K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC · 2023 · 2 generations on7descendants
- K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC · 2023 · cites it directly6descendants
- K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC · 2023 · 2 generations on6descendants
- K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC · 2022 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −27 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −26 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −25 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −24 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −23 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −22 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −21 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −20 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −19 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −18 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −17 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −16 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −15 | K040304 | Philips Intellivue Patient Monitor, Models MP40 & MP50 | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −14 | K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −13 | K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient… | Philips Medizin Systeme Boblingen GmbH | 2004 | — |
| −12 | K050141 | The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −11 | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −10 | K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −9 | K052801 | Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −8 | K053522 | Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −7 | K060221 | The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −6 | K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient… | Philips Medizin Systeme Boblingen GmbH | 2006 | 2 |
| −5 | K061052 | The Philips Intellivue Patient Monitors, Models… | Philips Medical Systems North America, Inc. | 2006 | — |
| −4 | K062283 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient… | Philips Medical Systems North America, Inc. | 2006 | — |
| −3 | K180881 | HemoSphere Advanced Monitor, HemoSphere Pressure Cable | Edwards Lifesciences, LLC | 2018 | — |
| −2 | K190205 | HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module | Edwards Lifesciences, LLC | 2019 | — |
| −1 | K201446 | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module | Edwards Lifesiences, LLC | 2020 | 1 |
| 0 (this device) | K203687 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension… | Edwards Lifesciences, LLC | 2021 | — |
| +1 | K213682 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry… | Edwards Lifesciences, LLC | 2022 | — |
| +2 | K223865 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted… | Edwards Lifesciences, LLC | 2023 | — |
| +1 | K231038 | Global Hypoperfusion Index (GHI) Algorithm | Edwards Lifesciences, LLC | 2023 | — |
| +2 | K223651 | Cerebral Adaptive Index (CAI) Algorithm | Edwards Lifesciences, LLC | 2023 | — |
| +1 | K221704 | HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global… | Edwards Lifesciences, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1985 | 3 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 6 | 0 |
| 1991 | 7 | 0 |
| 1992 | 7 | 0 |
| 1993 | 7 | 0 |
| 1994 | 3 | 0 |
| 1995 | 7 | 0 |
| 1996 | 10 | 0 |
| 1997 | 7 | 0 |
| 1998 | 16 | 0 |
| 1999 | 10 | 0 |
| 2000 | 22 | 0 |
| 2001 | 9 | 0 |
| 2002 | 17 | 0 |
| 2003 | 9 | 0 |
| 2004 | 19 | 0 |
| 2005 | 4 | 0 |
| 2006 | 9 | 0 |
| 2007 | 2 | 0 |
| 2008 | 9 | 0 |
| 2009 | 5 | 0 |
| 2010 | 6 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 1 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 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 DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 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 |
|---|---|---|---|
| * | K201446 | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleSummary page 7…DSB, Class II III. Predicate Device Primary HemoSphere Advanced Monitoring Platform manufactured by Edwards Predicate Device: Lifesciences, K201446 cleared October 1, 2020. Additional HemoSphere Advanced Monitoring Platform by Edwards Lifesciences, Predicate… | 2020 |
| * | K180881 | HemoSphere Advanced Monitor, HemoSphere Pressure CableSummary page 7…dicate Device: Lifesciences, K201446 cleared October 1, 2020. Additional HemoSphere Advanced Monitoring Platform by Edwards Lifesciences, Predicate K180881 cleared November 16, 2018, utilized for the Acumen Devices: Hypotension Prediction Index software feature.… | 2018 |
| * | DEN160044 | Acumen Hypotension Prediction Index (HPI) Feature SoftwareSummary page 7…s: Hypotension Prediction Index software feature. Acumen Hypotension Prediction Index feature by Edwards Lifesciences DEN160044, granted March 16, 2018 utilized for the Acumen Hypotension Prediction Index software feature. IV. Devi… | 2018 |
What descends from it? (18)
See all 184 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213682 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable… | 2022 | 14 |
| K231038 | Global Hypoperfusion Index (GHI) Algorithm | 2023 | 6 |
| K221704 | HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion… | 2022 | 6 |
| K230057 | Acumen Hypotension Prediction Index (HPI) Algorithm | 2023 | 5 |
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 back · ◆ in the 2016 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 9 companies; a new generation was cleared every 4 months on median.
- 35 of the 242 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K213682 (Edwards Lifesciences, LLC, 2022) has gone furthest, with 14 descendants of its own.
- 5 other devices also cite its predicate K201446.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, 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 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module: The HemoSphere Advanced Monitor when used with the HemoSphere Swan-Ganz Module and Edwards Swan-Ganz Catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output [continuous (CO) and intermittent (iCO)] and derived hemodynamic parameters. It may also be used for monitoring hemodynamic parameters in conjunction with a perioperative goal…
Read the full statement (807 words)
HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module:
The HemoSphere Advanced Monitor when used with the HemoSphere Swan-Ganz Module and Edwards Swan-Ganz Catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output [continuous (CO) and intermittent (iCO)] and derived hemodynamic parameters. It may also be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement below for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Oximetry Cable:
The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry Cable and Edwards oximetry catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of venous oxygen saturation (SvO2 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Pressure Cable:
The HemoSphere Advanced Monitor when used with the HemoSphere Pressure Cable is indicated for use in critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac, Acumen IQ and TruWave DPT sensor indications for use statement for information on target patient population specific to the sensor being used.
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 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.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Tissue Oximetry Module:
The noninvasive FORE-SIGHT ELITE tissue oximeter module is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the Sensors in individuals at risk for reduced-flow or no-flow ischemic states. The FORE-SIGHT ELITE tissue oximeter module is intended to allow for the display of StO2 on the HemoSphere advanced monitor.
• When used with large sensors is indicated for use on adults and transitional adolescents ≥40 kg.
• When used with Medium Sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for use on pediatric subjects ≥3 kg.
• When used with Small Sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for cerebral use on pediatric subjects <8 kg and non-cerebral use on pediatric subjects <5kg.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere ClearSight Module:
The HemoSphere advanced monitor when used with the HemoSphere ClearSight module, pressure controller and a compatible Edwards finger cuff are indicated for patients over 18 years of age in which the balance between cardiac function, fluid status and vascular resistance needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. In addition, the noninvasive system is indicated for use in patients with co-morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The HemoSphere advanced monitor and compatible Edwards finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.
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 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.
Refer to the ClearSight finger cuff and Acumen IQ finger cuff indications for use statements for information on target patient population specific to the finger cuff being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203687 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203687: HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203687
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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