510(k) Report

FDA applicant

Philips Volcano

San Diego, CA2 decisions2016–20171 recall

FDA records 2 decisions for Philips Volcano (San Diego, CA) from 2016 to 2017: 2 510(k) clearances. Most are in product codes PDU (Catheter For Crossing Total Occlusions) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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 Philips Volcano’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2016: 12017: 1
2016high 1 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2018

2018: 1
2016high 1 (2018) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Philips Volcano by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Philips Volcano’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?

  • PDUCatheter For Crossing Total Occlusions1decision
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K170133FFR V2.5Philips Volcano · 20171cites it

What has FDA decided for it lately?

  • K170133FFR V2.5Philips Volcano · 20171 recall
  • K162418Pioneer Plus CatheterPhilips Volcano · 2016

All 2 as Philips Volcano →

What has been recalled?

1 recall linked to its devices; the latest:

  • K170133Philips Volcano FFR software used in the following systems connected to the McKesson…Nov 7, 2018Class II