Atlas FDA

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

Carefusion Germany 234 GmbH · Predicate Candidate Screening

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

157 daysmedian FDA review time
242 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K153654Sentry WEB SmartInterpCarefusion Germany 234 GmbH2016-09-162700
K150810Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH2015-08-141411
K142959Vyntus WalkCarefusion Germany 234 GmbH2015-03-201570
K141936MICROBLAB, MICROLOOPCarefusion Germany 234 GmbH2014-12-291650
K133925VYNTUS/ SENTRYSUITE PRODUCT LINECarefusion Germany 234 GmbH2014-08-222420
K122699SENTRYSUITE PRODUCT LINECarefusion Germany 234 GmbH2012-11-19760
K113813SENTRYSUITE PRODUCT LINECarefusion Germany 234 GmbH2012-05-101390
K113096MICRO ICarefusion Germany 234 GmbH2012-04-131770
K111408MICROGARD IICarefusion Germany 234 GmbH2011-10-171510
K111053SENTRYSUITE PRODUCT LINECarefusion Germany 234 GmbH2011-08-121190
K101873MASTERSCREEN IOSCarefusion Germany 234 GmbH2011-02-102190
K092890ASTHMA MONITOR AM3Carefusion Germany 234 GmbH2010-01-131140

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