510(k) · Cleared
ClearedRadiomed Source
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiomed Corp. · KXK Source, Brachytherapy, Radionuclide
Cleared on Oct 24, 2000 as substantially equivalent to K874787 (Theragenics Corp., 1987) and 1 other predicate after a 204-day review. Its family tree reaches back 1 generation to 1987. 26 later devices descend from it.
- Decided
- Oct 24, 2000
- Review
- 204 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K874787 (1987). 2 ancestors in all. 26 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK874787 Modified Palladium Seed Model 100Theragenics Corp. · 1987
- This deviceK001070 Radiomed SourceRadiomed Corp. · 2000
- Descendant · cites it directly · 23 of its ownK013660 GenetraRadiomed Corporation · 2001
- Descendant · 2 generations on · 21 of its ownK022326 Radiomed MarkerRadiomed Corporation · 2003
- Descendant · 3 generations on · 20 of its ownK031206 Radiomed Soft Tissue MarkerRadiomed Corp. · 2003
- Descendant · 4 generations on · 11 of its ownK070305 Pre-Loaded VisicoilRadiomed Corporation · 2007
- Descendant · 4 generations on · 9 of its ownK080726 Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2008
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K013660GenetraRadiomed Corporation · 2001 · cites it directly23descendants
- K022326Radiomed MarkerRadiomed Corporation · 2003 · 2 generations on21descendants
- K031206Radiomed Soft Tissue MarkerRadiomed Corp. · 2003 · 3 generations on20descendants
- K070305Pre-Loaded VisicoilRadiomed Corporation · 2007 · 4 generations on11descendants
- K080726Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2008 · 4 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K874787 | Modified Palladium Seed Model 100 | Theragenics Corp. | 1987 | — |
| 0 (this device) | K001070 | Radiomed Source | Radiomed Corp. | 2000 | — |
| +1 | K013660 | Genetra | Radiomed Corporation | 2001 | — |
| +2 | K022326 | Radiomed Marker | Radiomed Corporation | 2003 | — |
| +3 | K031206 | Radiomed Soft Tissue Marker | Radiomed Corp. | 2003 | — |
| +4 | K070305 | Pre-Loaded Visicoil | Radiomed Corporation | 2007 | — |
| +4 | K080726 | Calypso 4D Localization System | Calypso Medical Technologies, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 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? (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 |
|---|---|---|---|
| * | K874787 | Modified Palladium Seed Model 100Summary page 1…lide 3. Identification of Predicate or Legally Marketed Device The predicate devices for the RadioMed™ Source are: Theragenics Pd-103 Seed K874787 Medi-Physics Rapid Strand™ K940632 Ir-192 Wires from Amersham International - Preammendments device… | 1987 |
| * | K940632 | I-125 Rapid StrandSummary page 1…rketed Device The predicate devices for the RadioMed™ Source are: Theragenics Pd-103 Seed K874787 Medi-Physics Rapid Strand™ K940632 Ir-192 Wires from Amersham International - Preammendments device 4. Device Description The Radio… | 1994 |
| * | — | Ir-192 Wires from Amersham International Named without a submission number |
What descends from it? (26)
See all 262 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?
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 RadioMed™ Source with activities from 0.1 to 5.0mCi per centimeter is
indicated for temporary or permanent interstitial implantation or surface
application to treat selected localized tumors. They can be used either as primary
treatment (such as for prostate cancer or unresectable tumors) or as treatment for
residual disease after excision of primary or recurrent tumors. The Pd-103
sources may be used concurrently with or following treatment with other
interventions, such as external beam therapy, hyperthermia, or chemotherapy.
Tumors of the head, neck, lung, pancreas, prostate and other accessible tumorsare
commonly treated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K001070 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001070: Radiomed Source.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001070
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026