Medtronic Advanced Energy: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Medtronic Advanced Energy” (first 2012, latest 2019), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 90 days. Since 2017 the median was 83 days, against 122 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 Medtronic, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 221 |
| 2013 | 2 | 80 |
| 2014 | 1 | 57 |
| 2015 | 1 | 104 |
| 2016 | 1 | 291 |
| 2017 | 3 | 48 |
| 2018 | 1 | 83 |
| 2019 | 1 | 255 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medtronic Advanced Energy took a median 83 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 10 | 10 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 1 | 1 |
Review panels
Most recent Medtronic Advanced Energy 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K183129 | Medtronic Total Hip Arthroplasty System | LPH | 2019-07-26 | 255 |
| K181257 | PlasmaBlade X 3.0S, PlasmaBlade X 4.0 | GEI | 2018-08-02 | 83 |
| K170381 | Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini | GEI | 2017-09-07 | 212 |
| K170610 | PlasmaBlade T | GEI | 2017-04-13 | 43 |
| K170296 | CoreCath 2.7S | GEI | 2017-03-20 | 48 |
| K152703 | PlasmaBlade TnA Tonsil and Adenoid Dissection Device | GEI | 2016-07-08 | 291 |
| K150297 | PlasmaBlade UPPP and Suction Coagulator | GEI | 2015-05-21 | 104 |
| K143175 | AEx Generator; PlasmaBlade T | GEI | 2014-12-31 | 57 |
| K132974 | AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR | GEI | 2013-12-03 | 71 |
| K123201 | AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER | GEI | 2013-01-10 | 90 |
1 earlier clearances. See the full list in Caduvo.
Recalls
12 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2016-12-28.
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.
- Medtronic Vascular (480 510(k)s)
- Medtronic Sofamor Danek (253 510(k)s)
- Medtronic, Inc. (247 510(k)s)
- Medtronic Sofamor Danek USA, Inc. (182 510(k)s)
- Medtronic Minimed (57 510(k)s)
- Medtronic Xomed, Inc. (47 510(k)s)
- Medtronic Navigation, Inc. (44 510(k)s)
- Medtronic Perfusion Systems (29 510(k)s)
- Medtronic Neurosurgery (27 510(k)s)
- Medtronic Blood Systems, Inc. (15 510(k)s)
- Medtronic PS Medical (14 510(k)s)
- Medtronic Ave, Inc. (13 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medtronic Advanced Energy?
FDA lists 11 510(k) clearances under the applicant name “Medtronic Advanced Energy” (first 2012, latest 2019), across 2 product codes in 2 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 Medtronic Advanced Energy?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medtronic Advanced Energy is 90 days. Since 2017: 83 days, versus 122 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Medtronic Advanced Energy?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 10); LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 1).
Next steps
- See all 11 Medtronic Advanced Energy clearances with predicates and recalls
- Run predicate analysis for product code GEI, Medtronic Advanced Energy'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.