Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
QAQ · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
265 daysmedian FDA review time
536 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242518 | Hypertension Prediction Index (HePI) Algorithm | Edwards Lifesciences, LLC | 2025-05-15 | 265 | 0 |
| K230057 | Acumen Hypotension Prediction Index (HPI) Algorithm | Edwards Lifesciences, LLC | 2023-06-08 | 150 | 0 |
| K203224 | Acumen Hypotension Prediction Index, HemoSphere Advanced Mon | Edwards Lifesciences, LLC | 2021-07-30 | 270 | 0 |
| K183646 | Acumen Hypotension Prediction Index – EV1000 Clinical Platfo | Edwards Lifeciences, LLC | 2019-05-21 | 146 | 0 |
| DEN160044 | Acumen Hypotension Prediction Index (HPI) Feature Software | Edwards Lifesciences, LLC | 2018-03-16 | 536 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda