Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Drager Medical AG & Co. Kgaa · 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) |
|---|---|---|---|---|---|
| K093632 | INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE | Drager Medical AG & Co. Kgaa | 2010-04-05 | 133 | 4 |
| K072412 | OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO | Drager Medical AG & Co. Kgaa | 2008-02-06 | 163 | 0 |
| K051263 | EVITAXL WITH OPTION SMARTCARE | Drager Medical AG & Co. Kgaa | 2005-07-12 | 57 | 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