510(k) Report

FDA applicant

Soundbite Medical Solution, Inc.

Montreal, CA1 decision2020–20200 recalls

FDA records 1 decision for Soundbite Medical Solution, Inc. (Montreal, CA) in 2020: 1 510(k) clearance. All are in product code PDU (Catheter For Crossing Total Occlusions). Its devices cite 1 predicate, 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 Soundbite Medical Solution, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2020: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Soundbite Medical Solution, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PDUCatheter For Crossing Total Occlusions1decision

Whose devices does it build on?

Its devices cite 1 predicate; 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.

  • K192211SoundBite Console, SoundBite Active Wire 18Soundbite Medical Solution, Inc. · 20201cites it

What has FDA decided for it lately?

  • K192211SoundBite Console, SoundBite Active Wire 18Soundbite Medical Solution, Inc. · 2020

The one decision as Soundbite Medical Solution, Inc. →

Other applicant names beginning “Soundbite”

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

Soundbite Medical Solutions, Inc. 2