510(k) · Cleared
Cleared`BI I-125 Brachytheraphy Seed, Model 125SL & 125SH
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Urocor, Inc. · KXK Source, Brachytherapy, Radionuclide
Cleared on Apr 16, 1999 as substantially equivalent to K914281 (Medi-Physics Inc. Dba Nycomed Amersham Imaging, 1991) after a 123-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Apr 16, 1999
- Review
- 123 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K914281 (1991). 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 deviceK984446 `BI I-125 Brachytheraphy Seed, Model 125SL & 125SHUrocor, 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) | K984446 | `BI I-125 Brachytheraphy Seed, Model 125SL & 125SH | Urocor, Inc. | 1999 | — |
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…: Technological Characteristics: SOURCE, BRACHYTHERAPY, RADIONUCLIDE MBI I-125 Brachytherapy Seed 1-125 Brachytherapy Seed Model 6711 by Amersham/Medi-Physics, Inc.(K914281) Each MBI I-125 Brachytherapy Seed external dimensions of 4.55 mm + 0.35 mm in length and 0.865 mm + 0.095 mm in diameter. The c… | 1991 |
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?
- Its one ancestor has no recall.
- 11 other devices also cite its predicate K914281.
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?
MBI 1-125 Brachytherapy Seeds with apparent activities between 3.7 MBq (0.1 mCi) to 37 MBq (1.0 mCi) are indicated for permanent interstitial treatment of tumors which are unresectable or residual after excision of the primary lesion, localized, slow growing, and exhibit low to moderate radiosensitivity. Intra abdominal, intrathoracic and superficial tumors may be treated with seeds containing apparent activities within this range. Tumors commonly…
Read the full statement (148 words)
MBI 1-125 Brachytherapy Seeds with apparent activities between 3.7 MBq (0.1 mCi) to 37 MBq (1.0 mCi) are indicated for permanent interstitial treatment of tumors which are unresectable or residual after excision of the primary lesion, localized, slow growing, and exhibit low to moderate radiosensitivity. Intra abdominal, intrathoracic and superficial tumors may be treated with seeds containing apparent activities within this range. Tumors commonly treated are prostate (early stage), pancreas, head, neck, and lung.
MBI I-125 Brachytherapy Seeds containing apparent activities greater than 37 MBq (1.0 mCi) are indicated for temporary interstitial treatment of tumors which are unresectable or residual after excision of the primary lesion, localized, and exhibit moderate radiosensitivity. Temporary implants are indicated in breast, brain and eye tumors.
MBI I-125 Brachytherapy Seeds are indicated for treatment of residual tumors and recurrent tumors following external radiation therapy, hyperthermia, or chemotherapy or concurrent with these treatment modalities.
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/K984446 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984446: `BI I-125 Brachytheraphy Seed, Model 125SL & 125SH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984446
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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