FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Acumen Assisted Fluid Management (AFM) Software Feature
K Number: DEN190029
·
Decision Nov 13, 2020
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
1
Applicant Total
21
Review Days
529
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Basic Information
- Device Name
- Acumen Assisted Fluid Management (AFM) Software Feature
- K Number
- DEN190029
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 870.5600
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Applicant
- Edwards Lifesciences
- Date Received
- June 3, 2019
- Decision Date
- November 13, 2020
- Product Code
- QMS
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QMS | Adjunctive Open Loop Fluid Therapy Recommender | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QMS), ordered by most recent decision date.
View allOther Clearances by Edwards Lifesciences
| K Number | Device Name | ||
|---|---|---|---|
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| K254279 | Edwards eSheath+ introducer set | Apr 17, 2026 | Substantially Equivalent |
| K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Dec 18, 2025 | Substantially Equivalent |
| K253034 | HemoSphere Stream Module | Oct 21, 2025 | Substantially Equivalent |
| K252364 | Edwards eSheath Optima introducer set | Aug 29, 2025 | Substantially Equivalent |
| K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2) | Jul 23, 2025 | Substantially Equivalent |
| K244046 | Edwards eSheath Optima introducer set | Mar 27, 2025 | Substantially Equivalent |
| K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) | Dec 9, 2024 | Substantially Equivalent |
| K240596 | Cerebral Autoregulation Index (CAI) Algorithm | Oct 16, 2024 | Substantially Equivalent |
| K241330 | Fogarty Fortis Arterial Embolectomy Catheter | Jul 2, 2024 | Substantially Equivalent |