Edwards Pacemaker Systems: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Edwards Pacemaker Systems” (first 1977, latest 1979), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 35 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXY | Implantable Pacemaker Pulse-Generator | 11 | 11 |
| DTC | Analyzer, Pacemaker Generator Function | 1 | 1 |
Plus 1 more product codes.
Review panels
- Cardiovascular (12)
Most recent Edwards Pacemaker Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K791751 | EDWARDS PACEMAKER 30 UNIPOLAR GENERATOR | DXY | 1979-09-26 | 21 |
| K790452 | 28 UNIPOLAR AND BIPOLAR PULSE GENERATORS | DXY | 1979-05-08 | 64 |
| K781111 | LEAD CONVERSION KIT, MODEL 341 | — | 1978-08-31 | 59 |
| K781144 | ANALYZER, PACER SYSTEM, PSA-5 | DTC | 1978-08-23 | 44 |
| K781042 | PROLITH 23S PACEMAKER | DXY | 1978-07-27 | 37 |
| K780780 | MICROPULSE 22S PACEMAKER | DXY | 1978-06-30 | 50 |
| K780238 | PACEMAKER, PROLITH 23U. PULSE GENERATOR | DXY | 1978-03-15 | 30 |
| K780091 | MICROPULSE 22U | DXY | 1978-01-30 | 14 |
| K771987 | MICROPULSE 26U PULSE GENERATOR | DXY | 1977-11-02 | 14 |
| K770657 | GENERATOR, PULSE, CARDIAC 2LU | DXY | 1977-04-26 | 19 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Edwards Pacemaker Systems.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Edwards Pacemaker Systems (a text match, not an official crosswalk):
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via DXY)
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via DXY)
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, LLC (156 510(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 Pacemaker Systems?
FDA lists 13 510(k) clearances under the applicant name “Edwards Pacemaker Systems” (first 1977, latest 1979), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Edwards Pacemaker Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Edwards Pacemaker Systems is 35 days.
Which FDA product codes appear under Edwards Pacemaker Systems?
The most frequent FDA product codes under this applicant name are DXY (Implantable Pacemaker Pulse-Generator, 11); DTC (Analyzer, Pacemaker Generator Function, 1).
Next steps
- See all 13 Edwards Pacemaker Systems clearances with predicates and recalls
- Run predicate analysis for product code DXY, Edwards Pacemaker Systems'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.