Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Ptw-Freiburg Physikalisch-Technische-Werkstaetten · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213370 | VERIQA | Ptw-Freiburg Physikalisch-Technische-Werkstaetten | 2022-03-30 | 169 | 1 |
| K191646 | Beamscan MR | Ptw-Freiburg Physikalisch-Technische-Werkstaetten | 2020-02-21 | 246 | 0 |
| K160405 | OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D | Ptw-Freiburg Physikalisch-Technische-Werkstaetten | 2017-10-20 | 612 | 1 |
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