Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rudolf Riester 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) |
|---|---|---|---|---|---|
| K190927 | Oscillometric Blood Pressure Monitor | Rudolf Riester GmbH | 2019-06-24 | 76 | 0 |
| K170538 | RVS-100 Vital Signs Monitor | Rudolf Riester GmbH | 2017-10-17 | 236 | 0 |
| K171182 | ri-former Predictive Thermometer | Rudolf Riester GmbH | 2017-10-04 | 163 | 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