De Novo · Granted
GrantedAcumen Assisted Fluid Management (AFM) Software Feature
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences · QMS Adjunctive Open Loop Fluid Therapy Recommender
Granted on Nov 13, 2020 as a new device type through De Novo after a 529-day review. 15 later devices descend from it.
- Decided
- Nov 13, 2020
- Review
- 529 days
- Class
- Class II
- Product code
- QMS
- Recalls
- None
15 later devices descend from it, 1 citing it directly.
- This deviceDEN190029 Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences · 2020
- 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 · 2 generations on · 6 of its ownK223651 Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC · 2023
- Descendant · 2 generations on · 6 of its ownK223127 HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight…Edwards Lifeciences, LLC · 2022
- Descendant · 3 generations on · 5 of its ownK230612 Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC · 2023
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · 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
- K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC · 2023 · 2 generations on6descendants
- K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC · 2022 · 2 generations on6descendants
- K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC · 2023 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN190029 | Acumen Assisted Fluid Management (AFM) Software Feature | Edwards Lifesciences | 2020 | — |
| +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 | — |
| +2 | K223651 | Cerebral Adaptive Index (CAI) Algorithm | Edwards Lifesciences, LLC | 2023 | — |
| +2 | K223127 | HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable | Edwards Lifeciences, LLC | 2022 | — |
| +3 | K230612 | Edwards Algorithm for Measurement of Blood Hemoglobin | Edwards Lifesciences, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 0 |
Sources: FDA De Novo 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 QMS? 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 QMS device
- #1 K233984 Acumen Assisted Fluid Management (AFM)…score 16.5 · 30 generations · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (15)
See all 151 later device cites 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 |
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?
- Of its descendants, K213682 (Edwards Lifesciences, LLC, 2022) has gone furthest, with 14 descendants of its own.
How does its category compare?
All QMS devicesQMS Adjunctive Open Loop Fluid Therapy Recommender: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QMS
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QMS
Too few QMS 510(k)s in any year since 2007 to give a median.
Recalls per year · QMS
No recall names QMS since 2007.
Adverse event reports per year · QMS
No MAUDE report names QMS since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Edwards Lifesciences Acumen Assisted Fluid Management (AFM) software feature provides the clinician with physiological insight into a patient's estimated response to fluid therapy and the associated hemodynamics. The Acumen AFM software feature is intended for use in surgical patients ≥18 years of age, that require advanced hemodynamic monitoring. The Acumen AFM software feature offers suggestions regarding the patient's physiological condition and…
Read the full statement (110 words)
The Edwards Lifesciences Acumen Assisted Fluid Management (AFM) software feature provides the clinician with physiological insight into a patient's estimated response to fluid therapy and the associated hemodynamics. The Acumen AFM software feature is intended for use in surgical patients ≥18 years of age, that require advanced hemodynamic monitoring. The Acumen AFM software feature offers suggestions regarding the patient's physiological condition and estimated response to fluid therapy. Acumen AFM fluid administration suggestions are offered to the clinician; the decision to administer a fluid bolus is made by the clinician, based upon review of the patient's hemodynamics. No therapeutic decisions should be made based solely on the Assisted Fluid Management suggestions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN190029 · printed Nov 3, 2026
Cite this page
510(k) Report. “DEN190029: Acumen Assisted Fluid Management (AFM) Software Feature.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/DEN190029
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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