Atlas FDA

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

Greiner Bio-One Vacuette North America · Predicate Candidate Screening

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

59 daysmedian FDA review time
175 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K080235SAFETY INFUSION SETGreiner Bio-One Vacuette North America2008-04-24850
K042927VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBESGreiner Bio-One Vacuette North America2005-04-151750
K033478VACUETTE QUICKSHIELD SAFETY TUBE HOLDERGreiner Bio-One Vacuette North America2003-12-29560
K023971VACUETTE TRACE ELEMENTS TUBESGreiner Bio-One Vacuette North America2003-01-27590
K011699VACUETTE EVACUATED BLOOD COLLECTION TUBESGreiner Bio-One Vacuette North America2001-06-28270

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