FDA Product Code
FDA Product Code QAQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2210
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K242518 | Hypertension Prediction Index (HePI) Algorithm | Edwards Lifesciences, LLC | 2025-05-15 | Traditional | PDF ↗ |
| K230057 | Acumen Hypotension Prediction Index (HPI) Algorithm | Edwards Lifesciences, LLC | 2023-06-08 | Traditional | PDF ↗ |
| K203224 | Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform | Edwards Lifesciences, LLC | 2021-07-30 | Traditional | PDF ↗ |
| 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 | Edwards Lifeciences, LLC | 2019-05-21 | Traditional | PDF ↗ |
| DEN160044 | Acumen Hypotension Prediction Index (HPI) Feature Software | Edwards Lifesciences, LLC | 2018-03-16 | Direct | — |
Product code QAQ · Class II · Cardiovascular. Data: openFDA.