Atlas FDA

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

Viasys Healthcare GmbH · Predicate Candidate Screening

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

104 daysmedian FDA review time
298 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K092324SPIROPROViasys Healthcare GmbH2009-09-03300
K091412CLEAN PEAK FLOW METERViasys Healthcare GmbH2009-08-211000
K091505COR12+Viasys Healthcare GmbH2009-06-10200
K081823MASTERSCREEN PAED - BABY BODYViasys Healthcare GmbH2009-05-183250
K080510VIP PULMONARY FUNCTION SYSTEMViasys Healthcare GmbH2008-08-201770
K080734FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CTViasys Healthcare GmbH2008-06-261040
K072061MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODYViasys Healthcare GmbH2008-04-222700
K072323MASTERSCREEN & OXYCON CPXViasys Healthcare GmbH2007-10-10510
K071753MASTERSCREEN PNEUMO & MASTERSCOPEViasys Healthcare GmbH2007-08-14470
K062011MODIFICATION TO FLOWSCREENViasys Healthcare GmbH2007-05-112980
K070614CORSCREENViasys Healthcare GmbH2007-05-04600
K040698MASTERSCREEN CPX AND OXYCON CPXViasys Healthcare GmbH2004-04-07210
K031515SPIROPRO SPO2Viasys Healthcare GmbH2003-11-141840
K031194SPIROSOFTViasys Healthcare GmbH2003-07-301050

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