Isoray Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Isoray Medical, Inc.” (first 2009, latest 2020), across 1 product code in 1 review panel. Median 510(k) review time under this name: 28 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 129 |
| 2019 | 0 | — |
| 2020 | 1 | 142 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Isoray Medical, Inc. took a median 136 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 132 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KXK | Source, Brachytherapy, Radionuclide | 5 | 5 |
Review panels
- Radiology (5)
Most recent Isoray Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202267 | Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles | KXK | 2020-12-31 | 142 |
| K180515 | GammaTile | KXK | 2018-07-06 | 129 |
| K111931 | GLIASITE RTS | KXK | 2011-08-05 | 28 |
| K092458 | PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2 | KXK | 2009-08-28 | 17 |
| K092136 | PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5 | KXK | 2009-08-07 | 23 |
Recalls
openFDA lists no recalls under a recalling firm named Isoray Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Isoray, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Isoray Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Isoray Medical, Inc.” (first 2009, latest 2020), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Isoray Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Isoray Medical, Inc. is 28 days.
Which FDA product codes appear under Isoray Medical, Inc.?
The most frequent FDA product codes under this applicant name are KXK (Source, Brachytherapy, Radionuclide, 5).
Next steps
- See all 5 Isoray Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KXK, Isoray Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.