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

Greiner Bio-One North America, Inc. · Predicate Candidate Screening

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

81 daysmedian FDA review time
245 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K233979VACUETTE® QUICKSHIELD Complete (Plus)Greiner Bio-One North America, Inc.2024-07-192140
K122687BLOOD CULTURE HOLDERGreiner Bio-One North America, Inc.2013-01-101280
K121908SAFETY INFUSION SETGreiner Bio-One North America, Inc.2012-07-25260
K113505VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDERGreiner Bio-One North America, Inc.2012-02-17810
K103041VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL Greiner Bio-One North America, Inc.2010-11-09260
K102774VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDERGreiner Bio-One North America, Inc.2010-10-15211
K081929VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SGreiner Bio-One North America, Inc.2008-12-161622
K072320GREINER VACUETTE QUICKSHIELD COMPLETEGreiner Bio-One North America, Inc.2007-09-14251
K063357MINICOLLECT CAPILLARY BLOOD COLLECTION TUBESGreiner Bio-One North America, Inc.2007-07-102450
K061483VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLESGreiner Bio-One North America, Inc.2006-08-14760

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