Atlas FDA

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

PJE · Predicate Candidate Screening

8 FDA 510(k) clearances under this product code; the 50 most recent screened below.

135 daysmedian FDA review time
344 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K231469PAXgene® Blood DNA TubePreanalytix GmbH2023-06-21300
K142821PAXgene Blood DNA TubePreanalytix GmbH2015-09-093440
K042927VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBESGreiner Bio-One Vacuette North America2005-04-151750
K031359S-MONOVETTE EDTA K2-GELSarstedt, Inc.2003-09-121350
K014104VACUETTE EDTA K2 TUBESGreiner Vacuette North America, Inc.2002-02-01500
K012043VACUETTE EDTA K2 GEL TUBESGreiner Vacuette North America, Inc.2001-09-24870
K010328MULTIPLE (IZON DNA BLOOD COLLECTION KIT)Izon Business Products, Inc.2001-04-09660
K972075VACUTAINER BRAND PPT PLASMA PREPARATION TUBEBecton Dickinson Vacutainer Systems1998-02-242660

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