Transparency Registry · DEN190029
Acumen Assisted Fluid Management (AFM) Software Feature
Edwards Lifesciences · cleared 2020-11-13 under product code QMS (Adjunctive Open Loop Fluid Therapy Recommender).
The public record
| 510(k) number | DEN190029 (FDA database) |
| Device name as cleared | Acumen Assisted Fluid Management (AFM) Software Feature |
| Applicant | Edwards Lifesciences (Irvine, CA, US) |
| Decision | Unknown · Direct pathway |
| Decision date | 2020-11-13 |
| FDA product code | QMS — Adjunctive Open Loop Fluid Therapy Recommender |
| Review panel | Cardiovascular |
Source: openFDA 510(k) records, stored verbatim. Entry added 2026-08-29; the source link above is authoritative if any discrepancy exists.
Public disclosure beyond the clearance
| FDA clearance record | Located — linked above |
| Public model card / intended-use document | Not yet located in public sources |
| Peer-reviewed validation publication | Not yet located in public sources |
| Published subgroup / equity performance | Not yet located in public sources |
| Public monitoring or update commitments | Not yet located in public sources |
"Not yet located" is a statement about what we could find in public sources — not a statement about the product or whether such materials exist privately. Vendors: these rows update free of charge on submission of a public link — start here.
Buying or governing this category?
The procurement instruments are free, the
agent privileging framework covers AI that
acts, and HAI-OS keeps the governance record once a
tool is deployed. This entry states public facts only and is not an
evaluation or recommendation of this product.