510(k) · Cleared
ClearedBebig Isoseed I-125
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bebig Isotopen-Und Medizintechnik GmbH · KXK Source, Brachytherapy, Radionuclide
Cleared on Dec 30, 2003 as substantially equivalent to K021343 (Bebig Isotopen-Und Medizintechnik GmbH, 2002) after a 26-day review. Its family tree reaches back 3 generations to 1980. 1 later device descends from it.
- Decided
- Dec 30, 2003
- Review
- 26 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K801748 (1980). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK801748 3M I-125 Seeds in Absorbable Carrier3M Company · 1980
- 2 generations backK982226 Uromed Brachytheraphy Iodine-125 SourcesUromed Corp. · 1999
- 1 generation backK021343 Isoseeds I-125Bebig Isotopen-Und Medizintechnik GmbH · 2002
- This deviceK033781 Bebig Isoseed I-125Bebig Isotopen-Und Medizintechnik GmbH · 2003
- Descendant · cites it directly · 0 of its ownK140849 IsoseedEckert & Ziegler Bebig GmbH · 2014
Most influential descendants
Showing 1 of 1 · See all- K140849IsoseedEckert & Ziegler Bebig GmbH · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K801748 | 3M I-125 Seeds in Absorbable Carrier | 3M Company | 1980 | — |
| −2 | K982226 | Uromed Brachytheraphy Iodine-125 Sources | Uromed Corp. | 1999 | — |
| −1 | K021343 | Isoseeds I-125 | Bebig Isotopen-Und Medizintechnik GmbH | 2002 | — |
| 0 (this device) | K033781 | Bebig Isoseed I-125 | Bebig Isotopen-Und Medizintechnik GmbH | 2003 | — |
| +1 | K140849 | Isoseed | Eckert & Ziegler Bebig GmbH | 2014 | — |
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 |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K021343 | Isoseeds I-125Summary page 1…, KXK Predicate Devices used for Substantial Equivalence Device Premarket # BEBIG Brachytherapy Iodine-125 Source K 021343 Intended Use The BEBIG 1-125 sources are intended for use in the treatment of cancer with radioactive sources in close proximity… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140849 | Isoseed | 2014 | 0 |
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?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K140849 (Eckert & Ziegler Bebig GmbH, 2014) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K021343.
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 BEBIG brachtherapy 1-125 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 as stated in the FDA summary.
https://510kreport.com/device/K033781 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033781: Bebig Isoseed I-125.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033781
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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