510(k) Report

FDA applicant

Sonora Medical Systems

Indianpolis, IN2 decisions2000–20010 recalls

FDA records 2 decisions for Sonora Medical Systems (Indianpolis, IN) from 2000 to 2001: 2 510(k) clearances. Most are in product codes ITX (Transducer, Ultrasonic, Diagnostic) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). 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, radiology panel, where it files most

How often FDA has decided Sonora Medical Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sonora Medical Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • ITXTransducer, Ultrasonic, Diagnostic1decision
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision

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 3 times; 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.

  • K994385Baby FaceSonora Medical Systems · 20003cite it

What has FDA decided for it lately?

  • K002856AT3C70 TransducerSonora Medical Systems · 2001
  • K994385Baby FaceSonora Medical Systems · 2000

All 2 as Sonora Medical Systems →

Other applicant names beginning “Sonora”

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

Sonora Respiratory Products, Inc. 1