Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Satelec - Acteon Group — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
214 daysmedian FDA review time
289 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233922 | SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; | Satelec - Acteon Group | 2024-03-11 | 89 | 0 |
| K172137 | PIEZOTOME CUBE | Satelec - Acteon Group | 2018-05-03 | 290 | 0 |
| K131906 | SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDI | Satelec - Acteon Group | 2014-04-11 | 289 | 0 |
| K132322 | NEWTRON P5 XS B.LED | Satelec - Acteon Group | 2014-03-11 | 229 | 0 |
| K132267 | NEWTRON P5, NEWTRON P5 B.LED | Satelec - Acteon Group | 2014-03-10 | 231 | 0 |
| K131151 | ENDOCENTER | Satelec - Acteon Group | 2014-01-16 | 268 | 0 |
| K131997 | NEWTRON BOOSTER | Satelec - Acteon Group | 2013-11-26 | 151 | 0 |
| K113430 | PROULTRA PIEZO ULTRASONIC | Satelec - Acteon Group | 2012-02-23 | 94 | 0 |
| K111623 | I-ENDO DUAL | Satelec - Acteon Group | 2012-01-10 | 214 | 0 |
| K072030 | IMPLANT CENTER | Satelec - Acteon Group | 2007-11-19 | 118 | 0 |
| K071424 | PMAX NEWTRON XS | Satelec - Acteon Group | 2007-08-24 | 93 | 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