FDA product code KXK: Source, Brachytherapy, Radionuclide
KXK is the FDA product code for source, brachytherapy, radionuclide. It is a Class II device, regulated under 21 CFR 892.5730 and reviewed by the Radiology panel. FDA has cleared 151 510(k) submissions under KXK, 4 in the last five years, from 79 different applicants. The average 510(k) review took 131 days (median 90); 218 days on average over the last three years. FDA has posted 7 recalls for KXK devices.
Classification
| Field | Value |
|---|---|
| Device name | Source, Brachytherapy, Radionuclide |
| Device class | Class II |
| Regulation | 21 CFR 892.5730 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for KXK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 90 |
| 2018 | 1 | 129 |
| 2019 | 2 | 78 |
| 2020 | 3 | 199 |
| 2022 | 1 | 166 |
| 2023 | 1 | 55 |
| 2025 | 2 | 218 |
Top KXK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cp Medical | 6 | 2007-07-18 |
| Implant Sciences Corp. | 6 | 2007-03-23 |
| Worldwide Medical Technologies, LLC | 6 | 2007-03-01 |
| Isoaid, LLC | 5 | 2025-07-15 |
| Isoray Medical, Inc. | 5 | 2020-12-31 |
74 more applicants have KXK clearances. See the full list in Caduvo.
Most recent KXK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252296 | Oncopatch, Inc. | OncoPatch | 2025-12-05 | 135 |
| K242818 | Isoaid, LLC | IsoSphere | 2025-07-15 | 300 |
| K223465 | Radiance Therapeutics, Inc. | RadianceTx Radionuclide Brachytherapy Source | 2023-01-11 | 55 |
| K221539 | Gt Medical Technologies | GammaTile | 2022-11-09 | 166 |
| K202267 | Isoray Medical, Inc. | Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles | 2020-12-31 | 142 |
Recalls for KXK devices
7 product recalls in 7 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-04-10.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code KXK?
KXK is the FDA product code for source, brachytherapy, radionuclide. It is a Class II device, regulated under 21 CFR 892.5730 and reviewed by the Radiology panel.
What device class is KXK?
Class II, regulation 21 CFR 892.5730. Typical premarket route: 510(k).
How long does a 510(k) take for product code KXK?
Across 151 cleared submissions the average was 131 days from receipt to decision (median 90).
Which companies have the most KXK clearances?
Cp Medical (6); Implant Sciences Corp. (6); Worldwide Medical Technologies, LLC (6); Isoaid, LLC (5); Isoray Medical, Inc. (5).
Have KXK devices been recalled?
Yes: 7 product recalls across 7 recall events; the most recent began 2018-04-10.
Next steps
- Run an FDA pathway report with predicate devices for product code KXK
- Run a recall and safety report across every KXK manufacturer
- Watch product code KXK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.