Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Em-Tec 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) |
|---|---|---|---|---|---|
| K111730 | SONOTT FLOWLAB(R) | Em-Tec GmbH | 2012-01-06 | 200 | 0 |
| K080704 | LOW FLUID ALARM | Em-Tec GmbH | 2008-04-17 | 36 | 0 |
| K040909 | SONO TT ULTRASONIC FLOWCOMPUTER | Em-Tec GmbH | 2004-04-20 | 12 | 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