510(k) Report

FDA applicant

Clarius Mobile Health Corp.

Vancouver, CA12 decisions2016–20260 recalls

FDA records 12 decisions for Clarius Mobile Health Corp. (Vancouver, CA) from 2016 to 2026: 12 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and QIH (Automated Radiological Image Processing Software). Since 2016 its 510(k)s took a median of 75 days from receipt to decision, against 117 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 7 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 Clarius Mobile Health Corp.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2016: 12017: 12018: 12019: 12021: 12023: 32024: 12025: 22026 (partial year): 1
2016high 3 (2023) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

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

Planning a device like Clarius Mobile Health Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic7decisions
  • QIHAutomated Radiological Image Processing Software5decisions

How long do its 510(k) reviews take?

Since 2016, its 12 510(k)s took a median of 75 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 117 days; 10 of its 12 were faster than that.

Whose devices does it build on?

Its devices cite 16 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 19 times; 7 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.

  • K192107Clarius Ultrasound ScannerClarius Mobile Health Corp. · 20197cite it
  • K222406Clarius AIClarius Mobile Health Corp. · 20233cite it
  • K163138Clarius Ultrasound SystemClarius Mobile Health Corp. · 20163cite it
  • K172385Clarius Ultrasound SystemClarius Mobile Health Corp. · 20172cite it
  • K213436Clarius Ultrasound ScannerClarius Mobile Health Corp. · 20212cite it
  • K180799Clarius Ultrasound ScannerClarius Mobile Health Corp. · 20181cites it

What has FDA decided for it lately?

  • K253593Clarius Ejection Fraction AIClarius Mobile Health Corp. · 2026
  • K250226Clarius Median Nerve AIClarius Mobile Health Corp. · 2025
  • K243853Clarius Prostate AIClarius Mobile Health Corp. · 2025
  • K233955Clarius OB AIClarius Mobile Health Corp. · 2024
  • K232257Clarius Bladder AIClarius Mobile Health Corp. · 2023
  • K232704Clarius Ultrasound ScannerClarius Mobile Health Corp. · 2023
  • K222406Clarius AIClarius Mobile Health Corp. · 2023
  • K213436Clarius Ultrasound ScannerClarius Mobile Health Corp. · 2021

All 12 as Clarius Mobile Health Corp. →