510(k) · Cleared
ClearedIsoseed
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eckert & Ziegler Bebig GmbH · KXK Source, Brachytherapy, Radionuclide
Cleared on Jul 2, 2014 as substantially equivalent to K002429 (Nucletron Corp., 2001) and 2 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1980.
- Decided
- Jul 2, 2014
- Review
- 90 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K801748 (1980). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK801748 3M I-125 Seeds in Absorbable Carrier3M Company · 1980
- 3 generations backK982226 Uromed Brachytheraphy Iodine-125 SourcesUromed Corp. · 1999
- 2 generations backK021343 Isoseeds I-125Bebig Isotopen-Und Medizintechnik GmbH · 2002
- 1 generation backK033781 Bebig Isoseed I-125Bebig Isotopen-Und Medizintechnik GmbH · 2003
- This deviceK140849 IsoseedEckert & Ziegler Bebig GmbH · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K801748 | 3M I-125 Seeds in Absorbable Carrier | 3M Company | 1980 | — |
| −3 | K982226 | Uromed Brachytheraphy Iodine-125 Sources | Uromed Corp. | 1999 | — |
| −2 | K021343 | Isoseeds I-125 | Bebig Isotopen-Und Medizintechnik GmbH | 2002 | — |
| −1 | K033781 | Bebig Isoseed I-125 | Bebig Isotopen-Und Medizintechnik GmbH | 2003 | — |
| 0 (this device) | K140849 | Isoseed | Eckert & Ziegler Bebig GmbH | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1997 | 2 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K002429 | Select Seed I-125Summary page 1…Radiology, Product code KXK Predicate Devices Device Premarket # Nucletron SelectSeed 1-125 K002429 Eckert & Ziegler BEBIG IsoSeed 1-125 K033781 Medi-Physics OncoSeed 6711 K914281 Device Description IsoSeed… | 2001 |
| * | K033781 | Bebig Isoseed I-125Summary page 1…KXK Predicate Devices Device Premarket # Nucletron SelectSeed 1-125 K002429 Eckert & Ziegler BEBIG IsoSeed 1-125 K033781 Medi-Physics OncoSeed 6711 K914281 Device Description IsoSeed 125.Sl7plus is a radioactive brachytherapy source… | 2003 |
| * | K914281 | I-125 Seeds, Code: 6711Summary page 1…Premarket # Nucletron SelectSeed 1-125 K002429 Eckert & Ziegler BEBIG IsoSeed 1-125 K033781 Medi-Physics OncoSeed 6711 K914281 Device Description IsoSeed 125.Sl7plus is a radioactive brachytherapy source intended for permanent as well as temporary implan… | 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?
- The line of descent spans 34 years and passes through 4 companies; a new generation was cleared every 10.5 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All KXK devicesKXK Source, Brachytherapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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?
IsoSeed 125.Sl7plus with apparent activities from 0.189 to 1.045 mCi are indicated for permanent interstitial implantation of selected localized tumors which are of low to moderate radiosensitivity. They may be used either as primary treatment (such as for prostate cancer or unresectable tumors) or for treatment of residual disease after excision of the primary tumor. Seeds in this apparent activity range may be used to treat superficial, intraabdominal…
Read the full statement (160 words)
IsoSeed 125.Sl7plus with apparent activities from 0.189 to 1.045 mCi are indicated for permanent interstitial implantation of selected localized tumors which are of low to moderate radiosensitivity. They may be used either as primary treatment (such as for prostate cancer or unresectable tumors) or for treatment of residual disease after excision of the primary tumor. Seeds in this apparent activity range may be used to treat superficial, intraabdominal, and intrathoracic tumors. Tumors of the head, neck, lung, pancreas, and prostate (early stages) are commonly treated.
IsoSeed 125.Sl7plus with total apparent activities greater than 1.045 mCi are indicated for interstitial treatment of tumors which have the following characteristics: unresectable, localized, and moderate radiosensitivity. These seeds may be used for selected radiation applications as temporary implants. IsoSeed 125.Sl7plus are indicated to treat residual tumors concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy. In addition, recurrent tumors may be implanted with IsoSeed 125.Sl7plus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140849 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140849: Isoseed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140849
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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