510(k) · Cleared
ClearedI3RAD 125 I Brachytherapy Seed, Model I125-0401
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Isotopes, Inc. · KXK Source, Brachytherapy, Radionuclide
Cleared on Sep 21, 1999 as substantially equivalent to K914825 (Endo Technic Corp., 1992) and 2 other predicates after a 19-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Sep 21, 1999
- Review
- 19 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K914281 (1991). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK914281 I-125 Seeds, Code: 6711Medi-Physics Inc. Dba Nycomed Amersham Imaging · 1991
- This deviceK992963 I3RAD 125 I Brachytherapy Seed, Model I125-0401International Isotopes, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914281 | I-125 Seeds, Code: 6711 | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1991 | — |
| 0 (this device) | K992963 | I3RAD 125 I Brachytherapy Seed, Model I125-0401 | International Isotopes, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KXK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KXK device
- #1 K242818 IsoSpherescore 10.9 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K914825 | 1-125 EndoseedSummary page 1…International Isotopes Inc. I3RAD '’I Seed Classification Name: Source, Radionuclide, Brachytherapy, 21 C.F.R. § 892.5730 Predicate Devices: EndoSeed, 510(k) number K914825/A Amersham Model 6711, K914281 Mentor IoGOLD, K972271 Tage $7 IV. Description of the Device: The I3RAD. '®I S… | 1992 |
| * | K914281 | I-125 Seeds, Code: 6711Summary page 1…AD '’I Seed Classification Name: Source, Radionuclide, Brachytherapy, 21 C.F.R. § 892.5730 Predicate Devices: EndoSeed, 510(k) number K914825/A Amersham Model 6711, K914281 Mentor IoGOLD, K972271 Tage $7 IV. Description of the Device: The I3RAD. '®I Seeds use '’ beads encapsulated i… | 1991 |
| * | K972271 | North American Scientific (Nasi) I-125 Radionuclide Brachytherapy Source- Model Med 3631-aSummary page 1…ion Name: Source, Radionuclide, Brachytherapy, 21 C.F.R. § 892.5730 Predicate Devices: EndoSeed, 510(k) number K914825/A Amersham Model 6711, K914281 Mentor IoGOLD, K972271 Tage $7 IV. Description of the Device: The I3RAD. '®I Seeds use '’ beads encapsulated in a titanium tube. V. I… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K914825.
How does its category compare?
All KXK devicesKXK Source, Brachytherapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KXK
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KXK
158in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KXK
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KXK
7in 2025
MAUDE reports naming product code KXK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 42 | 0 | 9 |
| 2008 | 1 | — | 1 | 15 |
| 2009 | 7 | 63 | 0 | 10 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 5 | 94 | 1 | 35 |
| 2012 | 3 | 109 | 1 | 4 |
| 2013 | 3 | 127 | 0 | 29 |
| 2014 | 8 | 96 | 0 | 13 |
| 2015 | 2 | — | 0 | 6 |
| 2016 | 4 | 49 | 1 | 40 |
| 2017 | 2 | — | 0 | 41 |
| 2018 | 1 | — | 0 | 28 |
| 2019 | 2 | — | 0 | 10 |
| 2020 | 3 | 158 | 0 | 15 |
| 2021 | 0 | — | 0 | 62 |
| 2022 | 1 | — | 0 | 26 |
| 2023 | 1 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 2 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
I3RAD '¥[ Seeds with activities from 0.1 to 1.0 mCi are indicated for permanent interstitial implantation in selected localized tumors. They can be used either as primary treatment (such as prostate cancer or unresectable tumors) or treatment of residual disease after excision of the primary tumor or recurring tumors. They may also be used at completion of external beam radiation therapy. Tumors of the head, neck, lung, pancreas, breast, prostate (early stages), and other accessible tumors are commonly treated.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992963 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992963: I3RAD 125 I Brachytherapy Seed, Model I125-0401.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992963
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026