510(k) Report

FDA applicant

Interson Corp.

Pleasanton, CA11 decisions1989–20230 recalls

FDA records 11 decisions for Interson Corp. (Pleasanton, CA) from 1989 to 2023: 11 510(k) clearances. Most are in product codes ITX (Transducer, Ultrasonic, Diagnostic) and IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Interson Corporation”.

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 Interson Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2017: 12023: 1
2007high 1 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Interson Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Interson Corp.’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?

  • ITXTransducer, Ultrasonic, Diagnostic6decisions
  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic2decisions
  • FEDEndoscopic Access Overtube, Gastroenterology-Urology1decision
  • FCGBiopsy Needle1decision
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K163443Interson USB Ultrasound SystemInterson Corporation · 20173cite it

What has FDA decided for it lately?

  • K233734Interson USB Ultrasound SystemInterson Corporation · 2023
  • K163443Interson USB Ultrasound SystemInterson Corporation · 2017
  • K911116Interson Endocavity Probe/Kontron Ultrasound SystInterson Corp. · 1991
  • K911117Interson Endocavity Probe for Atl Ultrasound SystInterson Corp. · 1991
  • K911113Interson Transrectal Probe/Kontron Ultrasound SystInterson Corp. · 1991
  • K911115Interson Transrectal Probe/Atl Ultrasound SystemInterson Corp. · 1991
  • K911114Interson Endocavity Probe/Aloka Ultrasound SystemInterson Corp. · 1991
  • K911464Interson Disposable Biopsy NeedleInterson Corp. · 1991

All 9 as Interson Corp. →All 2 as Interson Corporation →