Atlas FDA

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

Jms North America Corp. · Predicate Candidate Screening

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

126 daysmedian FDA review time
327 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K093637JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOJms North America Corp.2010-02-09770
K082882A.V. FISTULA BLUNT NEEDLE SETJms North America Corp.2009-01-211130
K070234JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETSJms North America Corp.2007-05-221260
K070143JMS PLANECTA STOPCOCKJms North America Corp.2007-04-10840
K051814JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLEJms North America Corp.2005-08-04300
K032975JMS BLOOD TUBING SETSJms North America Corp.2004-08-163270
K032977JMS BYPASS TUBEJms North America Corp.2004-05-252440
K040247PLUME SAFETY AVF NEEDLEJms North America Corp.2004-03-03290
K030479JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEJms North America Corp.2003-08-181860
K023668JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT)Jms North America Corp.2003-07-012430

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