Edwards Lifesciences, LLC: FDA clearances and approvals
Edwards Lifesciences, LLC has 156 FDA 510(k) clearances (first 1979, latest 2026), plus 18 PMA and 2 De Novo decisions, across 49 product codes in 5 review panels. Median 510(k) review time: 108 days. Since 2017 its median was 140 days, against 114 days for all cleared 510(k)s in the same product codes. openFDA lists 169 product recalls by a recalling firm named Edwards Lifesciences, LLC. It is the industry lead sponsor of 100 device clinical trials on ClinicalTrials.gov. It files with the SEC as Edwards Lifesciences Corp (EW).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 7 | 126 |
| 2013 | 7 | 143 |
| 2014 | 10 | 108 |
| 2015 | 6 | 92 |
| 2016 | 6 | 102 |
| 2017 | 4 | 92 |
| 2018 | 5 | 136 |
| 2019 | 6 | 64 |
| 2020 | 5 | 35 |
| 2021 | 4 | 128 |
| 2022 | 6 | 156 |
| 2023 | 9 | 168 |
| 2024 | 11 | 188 |
| 2025 | 9 | 107 |
| 2026 | 5 | 151 |
Review time against the same product codes
Since 2017, Edwards Lifesciences, LLC's cleared 510(k)s took a median 140 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 19 | 19 |
| DQK | Computer, Diagnostic, Programmable | 15 | 15 |
| DYB | Introducer, Catheter | 14 | 14 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 11 | 11 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 9 | 9 |
| KRH | Ring, Annuloplasty | 9 | 9 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 7 | 7 |
| DXE | Catheter, Embolectomy | 6 | 6 |
| DXC | Clamp, Vascular | 5 | 5 |
| DXO | Transducer, Pressure, Catheter Tip | 5 | 5 |
Plus 39 more product codes.
Review panels
- Cardiovascular (156)
- General and Plastic Surgery (8)
- Gastroenterology and Urology (7)
- General Hospital (3)
- Anesthesiology (2)
Most recent Edwards Lifesciences, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254232 | ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150) | PZX | 2026-06-26 | 179 |
| K251326 | Respiration Rate algorithm | BZQ | 2026-06-11 | 408 |
| K260105 | Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts | DXC | 2026-06-05 | 143 |
| K254279 | Edwards eSheath+ introducer set | DYB | 2026-04-17 | 108 |
| K253186 | HemoSphere Nano Monitor (HSNANO1) | DQK | 2026-02-24 | 151 |
| K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | DQK | 2025-12-18 | 128 |
| K253034 | HemoSphere Stream Module | DQK | 2025-10-21 | 29 |
| K251982 | Edwards MC3 Tricuspid annuloplasty ring (4900) | KRH | 2025-09-23 | 88 |
| K251688 | Carpentier-Edwards Physio Annuloplasty Ring (4450) | KRH | 2025-09-17 | 107 |
| K252364 | Edwards eSheath Optima introducer set | DYB | 2025-08-29 | 31 |
146 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250019 | PMA | SAPIEN M3 Transcatheter Mitral Valve Replacement System | 2025-12-22 |
| P230013 | PMA | Edwards EVOQUE Tricuspid Valve Replacement System | 2024-02-01 |
| P220003 | PMA | PASCAL Precision Transcatheter Valve Repair System | 2022-09-14 |
| DEN190029 | De Novo | Adjunctive Open Loop Fluid Therapy Recommender | 2020-11-13 |
| P200015 | PMA | Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System | 2020-08-31 |
Recalls
169 product recalls in 66 recall events; 21 initiated in the last five years. Most recent: 2026-03-27.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Edwards Lifesciences, LLC is the industry lead sponsor of 100 device studies on ClinicalTrials.gov (43 active or recruiting). Most recent:
- NCT07216573: The Continuity Study (Recruiting, started 2026-04)
- NCT07317648: ClearSight NextGen1 Study (Completed, started 2025-10-16)
- NCT07148323: HemoSphere Alta Study (Recruiting, started 2025-10-14)
- NCT07120048: Real World Data Collection on the INSPIRIS RESILIA Aortic Valve (Recruiting, started 2025-07-30)
- NCT07059793: MITRIS China Post Market Clinical Follow-up (PMCF) Study (Recruiting, started 2025-07-08)
SEC filings
Edwards Lifesciences Corp (EW): EDGAR filings, CIK 1099800. Matched by exact company name.
Frequently asked questions
How many FDA 510(k) clearances does Edwards Lifesciences, LLC have?
Edwards Lifesciences, LLC has 156 FDA 510(k) clearances (first 1979, latest 2026), plus 18 PMA and 2 De Novo decisions, across 49 product codes in 5 review panels.
How long does FDA take to clear Edwards Lifesciences, LLC's 510(k)s?
The median time from FDA receipt to decision across Edwards Lifesciences, LLC's cleared 510(k)s is 108 days. Since 2017: 140 days, versus 114 days for all cleared 510(k)s in the same product codes.
What devices does Edwards Lifesciences, LLC make?
Its most frequent FDA product codes are DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 19); DQK (Computer, Diagnostic, Programmable, 15); DYB (Introducer, Catheter, 14).
Has Edwards Lifesciences, LLC had device recalls?
openFDA lists 169 product recalls in 66 recall events by a recalling firm whose name matches Edwards Lifesciences, LLC; the most recent began 2026-03-27. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 156 Edwards Lifesciences, LLC clearances with predicates and recalls
- Run predicate analysis for product code DWF, Edwards Lifesciences, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.