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

Primeline Medical Products, Inc. · Predicate Candidate Screening

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

71 daysmedian FDA review time
295 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K022868PRIMAGARD SURGICAL EQUIPMENT DRAPESPrimeline Medical Products, Inc.2002-11-08710
K023266PRIMAGARD SURGICAL GOWNSPrimeline Medical Products, Inc.2002-11-08390
K023117PRIMAGARD SURGICAL GOWNSPrimeline Medical Products, Inc.2002-11-08580
K021864PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-Primeline Medical Products, Inc.2002-09-231090
K021076PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRPrimeline Medical Products, Inc.2002-04-16130
K011789PROCEDURE MASKS: PM4-301 AND PM4-304Primeline Medical Products, Inc.2001-06-22140
K001951PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEAPrimeline Medical Products, Inc.2000-09-08730
K971076PRIMED SHOE COVERS, PRIMED HEAD COVERSPrimeline Medical Products, Inc.1998-01-132950
K971075PRIMED PRIME-PLUS COTTON GAUZE SPONGESPrimeline Medical Products, Inc.1997-06-22900

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