Edwards Lifesciences, LLC: FDA filings under this applicant name
FDA lists 135 510(k) clearances under the applicant name “Edwards Lifesciences, LLC” (first 1979, latest 2026), plus 18 PMA and 1 De Novo decisions, across 47 product codes in 5 review panels. Median 510(k) review time under this name: 107 days. Since 2017 the median was 147 days, against 114 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Edwards Lifesciences, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 7 | 126 |
| 2013 | 7 | 143 |
| 2014 | 8 | 140 |
| 2015 | 5 | 75 |
| 2016 | 5 | 102 |
| 2017 | 4 | 92 |
| 2018 | 5 | 136 |
| 2019 | 6 | 64 |
| 2020 | 4 | 46 |
| 2021 | 4 | 128 |
| 2022 | 6 | 156 |
| 2023 | 9 | 168 |
| 2024 | 4 | 208 |
| 2025 | 4 | 142 |
| 2026 | 2 | 280 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Edwards Lifesciences, LLC took a median 147 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 | 18 | 18 |
| DQK | Computer, Diagnostic, Programmable | 12 | 12 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 10 | 10 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 9 | 9 |
| KRH | Ring, Annuloplasty | 9 | 9 |
| DYB | Introducer, Catheter | 8 | 8 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 7 | 7 |
| DXO | Transducer, Pressure, Catheter Tip | 5 | 5 |
| DYE | Replacement Heart-Valve | 5 | 0 |
| DQE | Catheter, Oximeter, Fiber-Optic | 4 | 4 |
Plus 37 more product codes.
Review panels
- Cardiovascular (135)
- Gastroenterology and Urology (7)
- General and Plastic Surgery (7)
- General Hospital (3)
- Anesthesiology (2)
Most recent Edwards Lifesciences, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251326 | Respiration Rate algorithm | BZQ | 2026-06-11 | 408 |
| K253186 | HemoSphere Nano Monitor (HSNANO1) | DQK | 2026-02-24 | 151 |
| K251982 | Edwards MC3 Tricuspid annuloplasty ring (4900) | KRH | 2025-09-23 | 88 |
| K251688 | Carpentier-Edwards Physio Annuloplasty Ring (4450) | KRH | 2025-09-17 | 107 |
| K242518 | Hypertension Prediction Index (HePI) Algorithm | QAQ | 2025-05-15 | 265 |
| K242909 | FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors | DRS | 2025-03-21 | 178 |
| K240078 | Fogarty Thru-Lumen Embolectomy Catheter | DXE | 2024-08-28 | 230 |
| K233984 | Acumen Assisted Fluid Management (AFM) Software Feature | QMS | 2024-08-02 | 228 |
| K233824 | Swan-Ganz catheter | DYG | 2024-06-06 | 188 |
| K233819 | Fogarty Venous Thrombectomy Catheters | DXE | 2024-05-22 | 173 |
125 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 |
| P200015 | PMA | Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System | 2020-08-31 |
| DEN160044 | De Novo | Adjunctive Predictive Cardiovascular Indicator | 2018-03-16 |
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 applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Edwards Lifesciences (21 510(k)s)
- Edwards Pacemaker Systems (13 510(k)s)
- Edwards Laboratories (12 510(k)s)
- Edwards Lifesciences Research Medical (6 510(k)s)
- Edwards Lifeciences, LLC (3 510(k)s)
- Edwards Lifesciences Services GmbH (3 510(k)s)
- Edwards Lifesiences, LLC (2 510(k)s)
- Edwards Orthopaedics Div., Baxter Healthcare Corp. (2 510(k)s)
- Edwards Lfesciences (1 510(k)s)
- Edwards Lifescience, LLC (1 510(k)s)
- Edwards Lifesciencess, LLC (1 510(k)s)
- Edwards Ventilator Co. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Edwards Lifesciences, LLC?
FDA lists 135 510(k) clearances under the applicant name “Edwards Lifesciences, LLC” (first 1979, latest 2026), plus 18 PMA and 1 De Novo decisions, across 47 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Edwards Lifesciences, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Edwards Lifesciences, LLC is 107 days. Since 2017: 147 days, versus 114 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Edwards Lifesciences, LLC?
The most frequent FDA product codes under this applicant name are DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 18); DQK (Computer, Diagnostic, Programmable, 12); DXG (Computer, Diagnostic, Pre-Programmed, Single-Function, 10).
Next steps
- See all 135 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. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.