510(k) Report

FDA applicant

Isoray Medical, Inc.

Richland, WA5 decisions2009–20200 recalls

FDA records 5 decisions for Isoray Medical, Inc. (Richland, WA) from 2009 to 2020: 5 510(k) clearances. All are in product code KXK (Source, Brachytherapy, Radionuclide). Its devices cite 5 predicates, 2 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 Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2009: 22011: 12018: 12020: 1
2009high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Isoray Medical, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Isoray Medical, 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, Radionuclide5decisions

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 2 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.

  • K111931Gliasite RTSIsoray Medical, Inc. · 20111cites it
  • K180515GammaTileIsoray Medical, Inc. · 20181cites it
  • K092136Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5Isoray Medical, Inc. · 20091cites it
  • K092458Proxcelan CS-131PRELOADED Strands, Model PL-1, Proxcelan CS-131 Preloaded Strands in 18 Guage Needles, Model…Isoray Medical, Inc. · 20091cites it

What has FDA decided for it lately?

  • K202267Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesIsoray Medical, Inc. · 2020
  • K180515GammaTileIsoray Medical, Inc. · 2018
  • K111931Gliasite RTSIsoray Medical, Inc. · 2011
  • K092458Proxcelan CS-131PRELOADED Strands, Model PL-1, Proxcelan CS-131 Preloaded Strands in 18 Guage Needles, Model…Isoray Medical, Inc. · 2009
  • K092136Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5Isoray Medical, Inc. · 2009

All 5 as Isoray Medical, Inc. →

Other applicant names beginning “Isoray”

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

Isoray, Inc. 3