510(k) Report

FDA applicant

Sonavex, Inc.

Baltimore, MD3 decisions2018–20250 recalls

FDA records 3 decisions for Sonavex, Inc. (Baltimore, MD) from 2018 to 2025: 3 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and NEU (Marker, Radiographic, Implantable). Since 2016 its 510(k)s took a median of 89 days from receipt to decision, against 89 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 1 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 Sonavex, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2018: 12019: 12025: 1
2018high 1 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Sonavex, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sonavex, Inc.’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, Ultrasonic2decisions
  • NEUMarker, Radiographic, Implantable1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 89 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 89 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K190039EchoSure Diagnostic Ultrasound SystemSonavex, Inc. · 20191cites it

What has FDA decided for it lately?

  • K243479EchoGuide (Version 1)Sonavex, Inc. · 2025
  • K190039EchoSure Diagnostic Ultrasound SystemSonavex, Inc. · 2019
  • K180621EchoMark, EchoMark LPSonavex, Inc. · 2018

All 3 as Sonavex, Inc. →