Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Edwards Lifeciences, LLC — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223127 | HemoSphere Advanced Monitoring Platform, HemoSphere ForeSigh | Edwards Lifeciences, LLC | 2022-11-07 | 35 | 0 |
| K183646 | Acumen Hypotension Prediction Index – EV1000 Clinical Platfo | Edwards Lifeciences, LLC | 2019-05-21 | 146 | 0 |
| K183413 | TruWave Disposable Pressure Transducer | Edwards Lifeciences, LLC | 2019-05-01 | 142 | 2 |
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