510(k) Report

FDA applicant

Salutaris Medical Devices, Inc.

Tucson, AZ2 decisions2014–20160 recalls

FDA records 2 decisions for Salutaris Medical Devices, Inc. (Tucson, AZ) from 2014 to 2016: 2 510(k) clearances. All are in product code KXK (Source, Brachytherapy, Radionuclide). 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 Salutaris Medical Devices, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2014: 12016: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Salutaris Medical Devices, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KXKSource, Brachytherapy, Radionuclide2decisions

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K142701SMD Sr90-1 Radionuclide Brachytherapy SourceSalutaris Medical Devices, Inc. · 20141cites it

What has FDA decided for it lately?

  • K163206SMD-Sr90-DA Radionuclide Brachytherapy SourceSalutaris Medical Devices, Inc. · 2016
  • K142701SMD Sr90-1 Radionuclide Brachytherapy SourceSalutaris Medical Devices, Inc. · 2014

All 2 as Salutaris Medical Devices, Inc. →