510(k) Report

FDA applicant

Jms North America Corp.

Hayward, CA19 decisions2003–20250 recalls

FDA records 19 decisions for Jms North America Corp. (Hayward, CA) from 2003 to 2025: 19 510(k) clearances. Most are in product codes FIE (Needle, Fistula) and FOZ (Catheter, Intravascular, Therapeutic…). Its devices cite 24 predicates, 9 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “JMS North America Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Jms North America Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007: 22009: 12010: 12011: 32013: 12014: 22015: 12018: 12025: 1
2007high 3 (2011) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Jms North America Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Jms North America Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FIENeedle, Fistula10decisions
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days2decisions
  • MPBCatheter, Hemodialysis, Non-Implanted1decision
  • FMFSyringe, Piston1decision
  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass1decision
  • FMGStopcock, I.V. Set1decision

Also: FPA (1), FJK (1), ONB (1).

Whose devices does it build on?

Its devices cite 24 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 9 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K070234JMS Sysloc Mini Avf and Apheresis Needle SetsJms North America Corp. · 20072cite it
  • K111948Wingeater V2JMS North America Corporation · 20112cite it
  • K142564JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)JMS North America Corporation · 20141cites it
  • K110157Sysloc Mini V3JMS North America Corporation · 20111cites it
  • K030479JMS Sysloc a.V. Fistula Needle Set, JMS Sysloc Apheresis Needle SetJms North America Corp. · 20031cites it
  • K093637JMS Blunt a. V. Fistula Needle Set with Site Preparation Tool Model 820-5300, 820-6300 and 820-7300Jms North America Corp. · 20101cites it

What has FDA decided for it lately?

  • K251877JMS CAVEO A.V. Fistula Needle SetJMS North America Corporation · 2025
  • K172499NeoshieldJMS North America Corporation · 2018
  • K151017JMS Harmony A.V. Fistula Needle SetJMS North America Corporation · 2015
  • K142564JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)JMS North America Corporation · 2014
  • K132321JMS SyringeJMS North America Corporation · 2014
  • K121488JMS Safe Wing Cath (SWC)JMS North America Corporation · 2013
  • K112178JMS Apheresis Needle Set Wingeater (R) V2JMS North America Corporation · 2011
  • K111948Wingeater V2JMS North America Corporation · 2011

All 10 as Jms North America Corp. →All 9 as JMS North America Corporation →