510(k) Report

FDA applicant

Volcano Corporation

San Diego, CA55 decisions2005–202129 recalls

FDA records 55 decisions for Volcano Corporation (San Diego, CA) from 2005 to 2021: 55 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and OBJ (Catheter, Ultrasound, Intravascular). Since 2016 its 510(k)s took a median of 70 days from receipt to decision, against 103 for FDA’s reviews in the same codes and years. Its devices cite 98 predicates, 51 of them its own earlier devices. 29 recalls are 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 Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2021

2007: 22008: 42009: 12010: 12011: 22012: 42013: 82014: 32015: 102016: 32017: 32018: 12019: 22020: 22021: 2
2007high 10 (2015) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

1in 2025

2007: 12010: 12012: 12013: 32015: 82016: 32017: 32018: 32022: 52025: 1
2007high 8 (2015) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Volcano Corporation’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?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic19decisions
  • OBJCatheter, Ultrasound, Intravascular14decisions
  • DQXWire, Guide, Catheter7decisions
  • OWBInterventional Fluoroscopic X-Ray System5decisions
  • DQYCatheter, Percutaneous3decisions
  • DXOTransducer, Pressure, Catheter Tip1decision

Also: DSK (1), DSA (1), DTK (1), MMX (1), KKX (1), QEZ (1).

How long do its 510(k) reviews take?

Since 2016, its 13 510(k)s took a median of 70 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 103 days; 9 of its 13 were faster than that.

Whose devices does it build on?

Its devices cite 98 predicates; 51 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 87 times; 51 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.

  • K133323Volcano Ifr ModalityVolcano Corporation · 20146cite it
  • K143701Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter, Visions PV .014 PlatinumVolcano Corporation · 20155cite it
  • K061215Volcano S51 Family of Imaging SystemsVolcano Corporation · 20064cite it
  • K111395Primewire Prestige PlusVolcano Corporation · 20114cite it
  • K150442Volcano Visions PV .018 Digital IVUS CatheterVolcano Corporation · 20154cite it
  • K051337Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus System, Model 8049XX-001Volcano Corporation · 20054cite it

What has FDA decided for it lately?

  • K210235Verrata PLUS Pressure Guide WireVolcano Corporation · 2021
  • K203719IntraSight MobileVolcano Corporation · 20211 recall
  • K202543OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-TipVolcano Corporation · 20201 recall
  • K192886OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-TipVolcano Corporation · 2020
  • K190626SyncVision SystemVolcano Corporation · 20191 recall
  • K190078IntraSightVolcano Corporation · 2019
  • K173860s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure…Volcano Corporation · 2018
  • K172455CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation KitVolcano Corporation · 20171 recall

All 55 as Volcano Corporation →

What has been recalled?

29 recalls linked to its devices; the latest:

  • K150442Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF…Jun 13, 2025Class II
  • K202543Philips OmniWire Pressure guide wire REF 89185J PN 300000252891May 16, 2022Class II
  • K153094Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only…May 13, 2022Class III
  • K121273Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only…May 13, 2022Class III
  • K203719IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102Jan 24, 2022Class III
  • K172574SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.xJan 19, 2022Class II

Other applicant names beginning “Volcano”

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

Volcano Atheromed, Inc. 7Volcano Therapeutics, Inc. 3Volcano Corporation (Dba Philips Image Guided Therapy… 1