Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hoffrichter GmbH — 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) |
|---|---|---|---|---|---|
| K053486 | TREND 200 CPAP DEVICE, MODEL 5CP201; TRENDSET PC SOFTWARE, M | Hoffrichter GmbH | 2006-01-04 | 20 | 0 |
| K041035 | HOFFRICHTER TREND 110 CPAP DEVICE WITH AQUATREND III CPAP HU | Hoffrichter GmbH | 2004-06-09 | 49 | 0 |
| K014074 | HOFFRICHTER VECTOR, VECTOR PLUS, VECTOR BI-VEVEL, VECTOR BI- | Hoffrichter GmbH | 2003-07-23 | 590 | 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