Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Draegerwerk AG & CO Kgaa · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
268 daysmedian FDA review time
352 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253647 | Evita (V800); Evita (V600) | Draegerwerk AG & CO Kgaa | 2026-05-07 | 168 | 0 |
| K242769 | VentStar Resus heated (N) (MP17030); VentStar Autobreath hea | Draegerwerk AG & CO Kgaa | 2025-04-04 | 203 | 0 |
| K222822 | VentStar Helix dual heated (N) Plus (MP02650), VentStar Heli | Draegerwerk AG & CO Kgaa | 2023-06-14 | 268 | 0 |
| K222024 | Evita V800, Evita V600 | Draegerwerk AG & CO Kgaa | 2023-05-16 | 309 | 0 |
| K222207 | Babylog VN800, Babylog VN600 | Draegerwerk AG & CO Kgaa | 2023-05-16 | 295 | 0 |
| K221118 | CO2 Mainstream Sensor | Draegerwerk AG & CO Kgaa | 2023-04-05 | 352 | 0 |
| K162821 | Babyleo TN500 | Draegerwerk AG & CO Kgaa | 2017-06-23 | 259 | 0 |
| K093633 | INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE | Draegerwerk AG & CO Kgaa | 2010-03-30 | 127 | 4 |
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