Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Drager Medizintechnik GmbH · Predicate Candidate Screening

8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

105 daysmedian FDA review time
279 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K023289OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072Drager Medizintechnik GmbH2003-01-151050
K010793OXYLOG 1000, MODEL 2M86840Drager Medizintechnik GmbH2001-12-202790
K012177VENTVIEW, MODEL 8414095Drager Medizintechnik GmbH2001-09-04540
K003068SAVINADrager Medizintechnik GmbH2001-06-252660
K010093NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474Drager Medizintechnik GmbH2001-06-141543
K010724SOLA 700,SOLA 500, SOLA 300Drager Medizintechnik GmbH2001-06-07875
K003067CALEODrager Medizintechnik GmbH2000-12-13720
K984611DRAGER SOLA SERIES, MODELS 1000/700/500/300Drager Medizintechnik GmbH1999-03-29900

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