510(k) Report

FDA applicant

Volcano Therapeutics, Inc.

Rancho Cordova,, CA3 decisions2004–20040 recalls

FDA records 3 decisions for Volcano Therapeutics, Inc. (Rancho Cordova,, CA) in 2004: 3 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and OBJ (Catheter, Ultrasound, Intravascular). Its devices cite 10 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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 Volcano Therapeutics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Volcano Therapeutics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision
  • OBJCatheter, Ultrasound, Intravascular1decision
  • DQXWire, Guide, Catheter1decision

Whose devices does it build on?

Its devices cite 10 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 0 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.

  • K041134Combomap Pressure and Flow SystemVolcano Therapeutics, Inc. · 20048cite it
  • K042188Volcano Therapeutics, Inc. Volcano Ivus SystemVolcano Therapeutics, Inc. · 20042cite it
  • K042996Combowire Pressure and Flow Guide Wire, Combotip Pressure and Flow Guide WireVolcano Therapeutics, Inc. · 20041cites it

What has FDA decided for it lately?

  • K042996Combowire Pressure and Flow Guide Wire, Combotip Pressure and Flow Guide WireVolcano Therapeutics, Inc. · 2004
  • K042188Volcano Therapeutics, Inc. Volcano Ivus SystemVolcano Therapeutics, Inc. · 2004
  • K041134Combomap Pressure and Flow SystemVolcano Therapeutics, Inc. · 2004

All 3 as Volcano Therapeutics, Inc. →

Other applicant names beginning “Volcano”

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

Volcano Corporation 55Volcano Atheromed, Inc. 7Volcano Corporation (Dba Philips Image Guided Therapy… 1