Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Drägerwerk AG Co. Kgaa · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
167 daysmedian FDA review time
297 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252746 | Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) | Drägerwerk AG Co. Kgaa | 2026-05-21 | 265 | 0 |
| K251619 | Babyleo TN500 | Drägerwerk AG & Co. KGaA | 2026-02-13 | 262 | 0 |
| K252827 | IBP cable Becton Dickinson (2606488); IBP cable Edwards (260 | Drägerwerk AG & Co. KGaA | 2025-12-01 | 87 | 0 |
| K230931 | Atlan | Drägerwerk AG Co. Kgaa | 2023-07-23 | 111 | 9 |
| K221836 | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinS | Drägerwerk AG & Co. KGaA | 2022-12-07 | 167 | 4 |
| K182859 | Babyleo TN500 | Dragerwerk AG & CO Kgaa | 2019-02-22 | 134 | 0 |
| K180779 | Savina 300 | Dragerwerk AG & CO Kgaa | 2019-01-17 | 297 | 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