Atlas FDA

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

Starplex Scientific, Inc. — Predicate Candidate Screening

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

139 daysmedian FDA review time
185 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K032246MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT Starplex Scientific, Inc.2003-08-13220
K022388STARTOX DRUG OF ABUSE SCREENING TEST (4)Starplex Scientific, Inc.2003-02-272190
K021006STARTOX DRUG OF ABUSE SCREENING TESTStarplex Scientific, Inc.2002-06-10740
K962843MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEMStarplex Scientific, Inc.1996-09-18580
K960997STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEMStarplex Scientific, Inc.1996-04-03220
K944847KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEMStarplex Scientific, Inc.1995-02-161390
K924362VACUPLUS TUBES WITH LAVANDER STOPPERSStarplex Scientific, Inc.1993-03-011850
K924364VACUPLUS TUBES WITH GREY STOPPERSStarplex Scientific, Inc.1993-03-011850
K924361VACUPLUS TUBES WITH GREEN STOPPERSStarplex Scientific, Inc.1993-03-011850
K924363VACUPLUS(R) STAR-SEP(TM)Starplex Scientific, Inc.1993-02-081640
K924365VACUPLUS TUBES WITH BRICK RED STOPPERSStarplex Scientific, Inc.1992-12-281220

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