Atlas FDA

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

Bayer Healthcare · Predicate Candidate Screening

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

86 daysmedian FDA review time
416 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K150942Contour Next USB Blood Glucose Monitoring SystemBayer Healthcare2015-11-252310
K151742Contour Next Control SolutionBayer Healthcare2015-09-23860
K122370CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITORBayer Healthcare2013-09-264160
K121087CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEMBayer Healthcare2012-06-28790
K110894CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METERBayer Healthcare2012-03-283640
K111268CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEMBayer Healthcare2012-03-063071
K091820CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFBayer Healthcare2009-08-26690
K062058ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STBayer Healthcare2006-09-11532
K060470ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; ASCENSIA MBayer Healthcare2006-04-12480

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