510(k) Report

FDA applicant

Sonic Incytes

Vancouver, CA4 decisions2020–20240 recalls

FDA records 4 decisions for Sonic Incytes (Vancouver, CA) from 2020 to 2024: 4 510(k) clearances. All are in product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). Since 2016 its 510(k)s took a median of 113 days from receipt to decision, against 177 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 3 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, radiology panel, where it files most

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

FDA decisions per year

1in 2024

2020: 12023: 22024: 1
2020high 2 (2023) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

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

Planning a device like Sonic Incytes’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, Ultrasonic4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 113 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 177 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 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.

  • K232459VelacurSonic Incytes · 20231cites it
  • K233977VelacurSonic Incytes · 20241cites it
  • K201597Liver Incytes, Model 1005Sonic Incytes · 20201cites it
  • K223287VelacurSonic Incytes · 20231cites it

What has FDA decided for it lately?

  • K233977VelacurSonic Incytes · 2024
  • K232459VelacurSonic Incytes · 2023
  • K223287VelacurSonic Incytes · 2023
  • K201597Liver Incytes, Model 1005Sonic Incytes · 2020

All 4 as Sonic Incytes →

Other applicant names beginning “Sonic”

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

Sonic Needle Corp. 1Sonic Incytes Medical Corp 1Sonic Systems, Inc. 1Sonic Innovations, Inc. 1