Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medtronic Advanced Energy · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
104 daysmedian FDA review time
291 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K183129 | Medtronic Total Hip Arthroplasty System | Medtronic Advanced Energy | 2019-07-26 | 255 | 0 |
| K181257 | PlasmaBlade X 3.0S, PlasmaBlade X 4.0 | Medtronic Advanced Energy | 2018-08-02 | 83 | 0 |
| K170381 | Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sea | Medtronic Advanced Energy | 2017-09-07 | 212 | 0 |
| K170610 | PlasmaBlade T | Medtronic Advanced Energy | 2017-04-13 | 43 | 0 |
| K170296 | CoreCath 2.7S | Medtronic Advanced Energy | 2017-03-20 | 48 | 0 |
| K152703 | PlasmaBlade TnA Tonsil and Adenoid Dissection Device | Medtronic Advanced Energy | 2016-07-08 | 291 | 0 |
| K150297 | PlasmaBlade UPPP and Suction Coagulator | Medtronic Advanced Energy | 2015-05-21 | 104 | 0 |
| K143175 | AEx Generator; PlasmaBlade T | Medtronic Advanced Energy | 2014-12-31 | 57 | 0 |
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