510(k) Report

510(k) · Cleared

Cleared

Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure

K183646510(k) TraditionalCleared May 21, 2019146-day reviewClass II21 CFR 870.2210

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Edwards Lifeciences, LLC · QAQ Adjunctive Predictive Cardiovascular Indicator

Cleared on May 21, 2019 as substantially equivalent to DEN160044 (Edwards Lifesciences, LLC, 2018) after a 146-day review. Its family tree reaches back 1 generation to 2018. 15 later devices descend from it.

Decided
May 21, 2019
Review
146 days
Class
Class II
Product code
QAQ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to DEN160044 (2018). 15 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2021: 3 descendants cleared2019: 1 descendant cleared2024: 3 descendants cleared2023: 2 descendants cleared2022: 1 descendant cleared2026: 2 descendants cleared2025: 3 descendants clearedDEN160044 · Acumen Hypotension Prediction Index (HPI) Feature Software · Edwards Lifesciences, LLC · 2018201620182020202220242026
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant5 generations forward: 2 descendants6 generations forward: 2 descendants DEN160044 · Acumen Hypotension Prediction Index (HPI) Feature Software · Edwards Lifesciences, LLC · 20180+5
  1. Root · 1 generation backDEN160044 Acumen Hypotension Prediction Index (HPI) Feature SoftwareEdwards Lifesciences, LLC · 2018
  2. This deviceK183646 Acumen Hypotension Prediction Index – EV1000 Clinical Platform…Edwards Lifeciences, LLC · 2019
  3. Descendant · cites it directly · 12 of its ownK200717 CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd. · 2021
  4. Descendant · 2 generations on · 6 of its ownK231038 Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC · 2023
  5. Descendant · 3 generations on · 5 of its ownK232294 HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™…Edwards Lifesciences, LLC · 2023
  6. Descendant · 4 generations on · 4 of its ownK242451 HemoSphere Alta Advanced Monitoring Platform…Edwards Lifesciences · 2024
  7. Descendant · 5 generations on · 2 of its ownK243781 HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module…Edwards Lifesciences · 2025 · Recalled

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2019: 12021: 32022: 12023: 22024: 32025: 32026: 2
2019high 3 (2021) · low 0 (2020)2026

Most influential descendants

Showing 5 of 15 · See all
  • K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd. · 2021 · cites it directly12descendants
  • K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC · 2023 · 2 generations on6descendants
  • K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC · 2023 · 3 generations on5descendants
  • K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences · 2024 · 4 generations on4descendants
  • K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences · 2025 · 5 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1DEN160044Acumen Hypotension Prediction Index (HPI) Feature SoftwareEdwards Lifesciences, LLC2018—
0 (this device)K183646Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen…Edwards Lifeciences, LLC2019—
+1K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.2021—
+2K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC2023—
+3K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced…Edwards Lifesciences, LLC2023—
+4K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1)…Edwards Lifesciences2024—
+5K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10)…Edwards Lifesciences20251

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202130
202210
202320
202430
202530
202620
FIG. 1 — Lineage of K183646, 2018–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 QAQ? 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 QAQ device

  1. #1 K230057 Acumen Hypotension Prediction Index (HPI)…score 19.6 · 28 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*DEN160044Acumen Hypotension Prediction Index (HPI) Feature Software
Summary page 4
…r Indicator Name Regulation 21 CFR 870.2210/Class II/QAQ Class / Product Code Predicate Acumen Hypotension Prediction Index, DEN160044 Device(s) The Acumen Hypotension Prediction Index Feature (DEN160044) consists of…
Edwards Lifesciences, LLC2018—

Also cleared against DEN160044: 4 other devices →

What descends from it? (15)

See all 15

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112
K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC20210
K192058EV1000 Clinical Platform NI, EV1000 Clinical PlatformEdwards Lifesciences, LLC20190

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?

  • Its one ancestor has no recall.
  • Of its descendants, K200717 (Clew Medical, Ltd., 2021) has gone furthest, with 12 descendants of its own.
  • 4 other devices also cite its predicate DEN160044.

How does its category compare?

All QAQ devices

QAQ Adjunctive Predictive Cardiovascular Indicator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · QAQ

1in 2025

2018: 12019: 12021: 12023: 12025: 1
2007high 1 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QAQ

Too few QAQ 510(k)s in any year since 2007 to give a median.

Recalls per year · QAQ

No recall names QAQ since 2007.

Adverse event reports per year · QAQ

14in 2025

2021: 12022: 22023: 82024: 52025: 14
2007high 14 (2025) · low 0 (2007)2025

MAUDE reports naming product code QAQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20181—00
20191—00
20200—00
20211—01
20220—02
20231—08
20240—05
20251—014
20260—0—

What is it indicated for?

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 non-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.

Indications for use as stated in the FDA summary.

Also cleared against DEN160044

4 other devices cite the same predicate.

  • K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC · 2023
  • K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction IndexEdwards Lifesciences, LLC · 2021
  • K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd. · 2021
  • K180881HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC · 2018

More from Edwards Lifeciences, LLC

3 FDA decisions under this applicant name. See the company

  • K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC · 2022
  • K183413TruWave Disposable Pressure TransducerEdwards Lifeciences, LLC · 20192 recalls

Recent decisions in QAQ

The QAQ category page

  • K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC · 2025
  • K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC · 2023
  • K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC · 2021
  • DEN160044Acumen Hypotension Prediction Index (HPI) Feature SoftwareEdwards Lifesciences, LLC · 2018

https://510kreport.com/device/K183646 · printed Nov 6, 2026

Cite this page

510(k) Report. “K183646: Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183646

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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