Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sopro - Acteon Group — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K153367 | S698 Symbioz flow | Sopro - Acteon Group | 2016-06-17 | 207 | 0 |
| K142995 | SOPIX | Sopro - Acteon Group | 2015-08-17 | 305 | 0 |
| K151053 | PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Im | Sopro - Acteon Group | 2015-07-31 | 102 | 0 |
| K140013 | SOPIX INSIDE, SOPIX2 INSIDE | Sopro - Acteon Group | 2014-09-05 | 246 | 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