Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Draeger Medical AG & Co. KG · Predicate Candidate Screening

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

139 daysmedian FDA review time
396 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K102618VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATEDDraeger Medical AG & Co. KG2010-12-10880
K092029VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE Draeger Medical AG & Co. KG2010-08-063960
K100941INFINITY MCABLE - MAINSTREAM CO2Draeger Medical AG & Co. KG2010-04-23180
K092999NBP CUFFDraeger Medical AG & Co. KG2009-11-24570
K083050EVITE XLDraeger Medical AG & Co. KG2008-12-29760
K081447FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLODraeger Medical AG & Co. KG2008-10-081390
K081743CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKSDraeger Medical AG & Co. KG2008-09-22952
K072884FABIUS MRIDraeger Medical AG & Co. KG2008-07-302952
K072885CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 570Draeger Medical AG & Co. KG2008-04-071811
K072002FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR Draeger Medical AG & Co. KG2008-01-311920

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