Atlas FDA

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

JMS North America Corporation · Predicate Candidate Screening

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

103 daysmedian FDA review time
291 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K251877JMS CAVEO A.V. Fistula Needle SetJMS North America Corporation2025-08-15580
K172499NEOSHIELDJMS North America Corporation2018-06-012870
K151017JMS Harmony A.V. Fistula Needle SetJMS North America Corporation2015-05-13270
K142564JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINJMS North America Corporation2014-12-231030
K132321JMS SYRINGEJMS North America Corporation2014-02-202100
K121488JMS SAFE WING CATH (SWC)JMS North America Corporation2013-03-052910
K112178JMS APHERESIS NEEDLE SET WINGEATER(R) V2JMS North America Corporation2011-10-27910
K111948WINGEATER V2JMS North America Corporation2011-10-241080
K110157SYSLOC MINI V3JMS North America Corporation2011-02-11230

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