510(k) Report

FDA applicant

Isoray, Inc.

Richland, WA3 decisions2003–20130 recalls

FDA records 3 decisions for Isoray, Inc. (Richland, WA) from 2003 to 2013: 3 510(k) clearances. All are in product code KXK (Source, Brachytherapy, Radionuclide). Its devices cite 10 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 Isoray, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Isoray, Inc.’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?

  • KXKSource, Brachytherapy, Radionuclide3decisions

Whose devices does it build on?

Its devices cite 10 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.

  • K062384Cesium-131 Strand, Strand Preload, Preload, S-CartridgeIsoray, Inc. · 20062cite it
  • K030162Lawrence Cserion, Model CS-1Isoray, Inc. · 20031cites it

What has FDA decided for it lately?

  • K132996Cesitrx, (Liquid Cesium-131 Solution) for Use with Gliasite RTSIsoray, Inc. · 2013
  • K062384Cesium-131 Strand, Strand Preload, Preload, S-CartridgeIsoray, Inc. · 2006
  • K030162Lawrence Cserion, Model CS-1Isoray, Inc. · 2003

All 3 as Isoray, Inc. →

Other applicant names beginning “Isoray”

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

Isoray Medical, Inc. 5