510(k) · Cleared
ClearedUromed Brachytheraphy Iodine-125 Sources
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Uromed Corp. · KXK Source, Brachytherapy, Radionuclide
Cleared on May 13, 1999 as substantially equivalent to K801748 (3M Company, 1980) and 3 other predicates after a 323-day review. Its family tree reaches back 1 generation to 1980. 20 later devices descend from it.
- Decided
- May 13, 1999
- Review
- 323 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K801748 (1980). 4 ancestors in all. 20 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK801748 3M I-125 Seeds in Absorbable Carrier3M Company · 1980
- This deviceK982226 Uromed Brachytheraphy Iodine-125 SourcesUromed Corp. · 1999
- Descendant · cites it directly · 18 of its ownK021343 Isoseeds I-125Bebig Isotopen-Und Medizintechnik GmbH · 2002
- Descendant · cites it directly · 14 of its ownK040339 Brachytherapy Strand DeviceBebig Isotopen-Und Medizintechnik GmbH · 2004
- Descendant · 2 generations on · 9 of its ownK043596 Theraload Custom Loaded Needles, Models 200 and 125.S06Theragenics Corp. · 2005
- 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
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K021343Isoseeds I-125Bebig Isotopen-Und Medizintechnik GmbH · 2002 · cites it directly18descendants
- K040339Brachytherapy Strand DeviceBebig Isotopen-Und Medizintechnik GmbH · 2004 · cites it directly14descendants
- K043596Theraload Custom Loaded Needles, Models 200 and 125.S06Theragenics Corp. · 2005 · 2 generations on9descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K801748 | 3M I-125 Seeds in Absorbable Carrier | 3M Company | 1980 | — |
| 0 (this device) | K982226 | Uromed Brachytheraphy Iodine-125 Sources | Uromed Corp. | 1999 | — |
| +1 | K021343 | Isoseeds I-125 | Bebig Isotopen-Und Medizintechnik GmbH | 2002 | — |
| +1 | K040339 | Brachytherapy Strand Device | Bebig Isotopen-Und Medizintechnik GmbH | 2004 | — |
| +2 | K043596 | Theraload Custom Loaded Needles, Models 200 and 125.S06 | Theragenics Corp. | 2005 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1997 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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? (4)
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 |
|---|---|---|---|
| * | K801748 | 3M I-125 Seeds in Absorbable CarrierSummary page 1…): 21 CFR 892.5730 Radionuclide Brachytherapy Source Predicate Devices used for Substantial Equivalence Device ' Premarket # Amersham I-125 Seeds in Absorbable Carrier K801748 (formerly marketed by 3M Co.) North American Scientific I-125 Radionuclide Brachytherapy Sources K972271 North American Scienti… | 1980 |
| * | K972271 | North American Scientific (Nasi) I-125 Radionuclide Brachytherapy Source- Model Med 3631-aSummary page 1…evice ' Premarket # Amersham I-125 Seeds in Absorbable Carrier K801748 (formerly marketed by 3M Co.) North American Scientific I-125 Radionuclide Brachytherapy Sources K972271 North American Scientific I-125 o Radionuclide Brachytherapy Sources K964647 Theragenics Modified Paladium Seed K874787 Intende… | 1997 |
| * | K964647 | North American Scientific (Nasi) 1-125 Radionuclide Brachytherapy SourceSummary page 1…rly marketed by 3M Co.) North American Scientific I-125 Radionuclide Brachytherapy Sources K972271 North American Scientific I-125 o Radionuclide Brachytherapy Sources K964647 Theragenics Modified Paladium Seed K874787 Intended Use The UroMed Brachytherapy lodine-125 Sources are intended for use in the… | 1997 |
| * | K874787 | Modified Palladium Seed Model 100Summary page 1…ntific I-125 Radionuclide Brachytherapy Sources K972271 North American Scientific I-125 o Radionuclide Brachytherapy Sources K964647 Theragenics Modified Paladium Seed K874787 Intended Use The UroMed Brachytherapy lodine-125 Sources are intended for use in the treatment of cancer with radioactive sourc… | 1987 |
What descends from it? (20)
See all 203 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 ancestors has a recall.
- Of its descendants, K021343 (Bebig Isotopen-Und Medizintechnik GmbH, 2002) has gone furthest, with 18 descendants of its own.
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?
The UroMed I-125 Radionuclide Brachytherapy Sources are indicated for the treatment of selected localized tumors. These sources are commonly used to treat superficial, intra-abdominal, and intrathoracic tumors. Tumors of the head, neck, lung, pancreas and prostate are commonly treated. They may be used alone, or in combination with external beam radiation.
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/K982226 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982226: Uromed Brachytheraphy Iodine-125 Sources.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982226
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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