510(k) Report

FDA applicant

Jomed, Inc.

Rancho Cordova,, CA9 decisions2001–20031 recall

FDA records 9 decisions for Jomed, Inc. (Rancho Cordova,, CA) from 2001 to 2003: 9 510(k) clearances. Most are in product codes DQX (Wire, Guide, Catheter) and FGE (Stents, Drains And Dilators For The Biliary…). Its devices cite 15 predicates, 2 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Jomed AG”.

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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Jomed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Jomed, Inc. since 2007.

Recalls per year

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

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

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Which product codes does it file in?

  • DQXWire, Guide, Catheter3decisions
  • FGEStents, Drains And Dilators For The Biliary Ducts1decision
  • OBJCatheter, Ultrasound, Intravascular1decision
  • DQYCatheter, Percutaneous1decision
  • LITCatheter, Angioplasty, Peripheral, Transluminal1decision
  • DQOCatheter, Intravascular, Diagnostic1decision

Also: DXK (1).

Whose devices does it build on?

Its devices cite 15 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 54 times; 2 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.

  • K022762Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 &…Jomed, Inc. · 200223cite it
  • K031277Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 200312cite it
  • K031148IN-Vision Imaging SystemJomed, Inc. · 20036cite it
  • K021219Smartwire/Smartmap Pressure SystemJomed, Inc. · 20026cite it
  • K020854Modification to Fox Pta CatheterJomed AG · 20023cite it
  • K010838Fox Pta Catheter, 3.0, 4.0, 5.0, 6.0, 7.0, and 8.0 X 40 MM, Models A14003, A14004, A14005, A14006, A14007…Jomed AG · 20012cite it

What has FDA decided for it lately?

  • K031346Jovus Eagle Eye F/X 2.9F Ivus Catheter, Model 85900Jomed, Inc. · 2003
  • K031148IN-Vision Imaging SystemJomed, Inc. · 2003
  • K031277Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003
  • K030053Jostent Selfx, Models 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810Jomed AG · 2003
  • K022762Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 &…Jomed, Inc. · 2002
  • K021219Smartwire/Smartmap Pressure SystemJomed, Inc. · 2002
  • K020854Modification to Fox Pta CatheterJomed AG · 2002
  • K010838Fox Pta Catheter, 3.0, 4.0, 5.0, 6.0, 7.0, and 8.0 X 40 MM, Models A14003, A14004, A14005, A14006, A14007…Jomed AG · 2001

All 6 as Jomed, Inc. →All 3 as Jomed AG →

What has been recalled?

1 recall linked to its devices; the latest:

  • K003938Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use.…Aug 13, 2014Class II

Other applicant names beginning “Jomed”

FDA records each applicant name separately; these may or may not be the same firm.

Jomed Catheter, Inc. 1Jomed Imaging, Ltd. 1