510(k) · Cleared
ClearedIntersource 125, Model 1251L
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Brachytherapy, Inc. · KXK Source, Brachytherapy, Radionuclide
Cleared on Jun 9, 1999 as substantially equivalent to K914281 (Medi-Physics Inc. Dba Nycomed Amersham Imaging, 1991) after a 196-day review. Its family tree reaches back 1 generation to 1991. 9 later devices descend from it.
- Decided
- Jun 9, 1999
- Review
- 196 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K914281 (1991). 9 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK914281 I-125 Seeds, Code: 6711Medi-Physics Inc. Dba Nycomed Amersham Imaging · 1991
- This deviceK984235 Intersource 125, Model 1251LInternational Brachytherapy, Inc. · 1999
- Descendant · cites it directly · 8 of its ownK041702 EZ-Pak (EZ-Pak IS a Trademark of Ibt S.a.)Ibt SA · 2004
- Descendant · 2 generations on · 7 of its ownK062384 Cesium-131 Strand, Strand Preload, Preload, S-CartridgeIsoray, Inc. · 2006
- Descendant · 3 generations on · 4 of its ownK092136 Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5Isoray Medical, Inc. · 2009
- Descendant · 4 generations on · 3 of its ownK180515 GammaTileIsoray Medical, Inc. · 2018
- Descendant · 5 generations on · 2 of its ownK190296 GammaTileGt Medical Technologies · 2019
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K041702EZ-Pak (EZ-Pak IS a Trademark of Ibt S.a.)Ibt SA · 2004 · cites it directly8descendants
- K062384Cesium-131 Strand, Strand Preload, Preload, S-CartridgeIsoray, Inc. · 2006 · 2 generations on7descendants
- K092136Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5Isoray Medical, Inc. · 2009 · 3 generations on4descendants
- K180515GammaTileIsoray Medical, Inc. · 2018 · 4 generations on3descendants
- K190296GammaTileGt Medical Technologies · 2019 · 5 generations on2descendants
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) | K984235 | Intersource 125, Model 1251L | International Brachytherapy, Inc. | 1999 | — |
| +1 | K041702 | EZ-Pak (EZ-Pak IS a Trademark of Ibt S.a.) | Ibt SA | 2004 | — |
| +2 | K062384 | Cesium-131 Strand, Strand Preload, Preload, S-Cartridge | Isoray, Inc. | 2006 | — |
| +3 | K092136 | Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5 | Isoray Medical, Inc. | 2009 | — |
| +4 | K180515 | GammaTile | Isoray Medical, Inc. | 2018 | — |
| +5 | K190296 | GammaTile | Gt Medical Technologies | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 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? (1)
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 |
|---|---|---|---|
| * | K914281 | I-125 Seeds, Code: 6711Summary page 1…ant sources. Substantial Equivalence: InterSource'® is substantially equivalent to the Amersham/Medi+Physics Model 6711 Therapeutic Seed Source (Premarket Notification #K914281), a Class Il post-amendment device granted clearance to market on 22 Nov 1991. 8.2 The contents of this premarket notification s… | 1991 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041702 | EZ-Pak (EZ-Pak IS a Trademark of Ibt S.a.) | 2004 | 8 |
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?
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?
InterSource® implants are indicated for interstitial implantation of select localized tumors with low to moderate radiosensitivity. They are used either as primary treatment for tumors such as those of the head, lung, neck, pancreas, prostate, and unresectable tumors, or for residual disease after excision of the primary tumor. InterSource® implants are indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy.
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/K984235 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984235: Intersource 125, Model 1251L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984235
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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