510(k) · Cleared
ClearedGenetra
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiomed Corporation · KXK Source, Brachytherapy, Radionuclide
Cleared on Dec 5, 2001 as substantially equivalent to K001070 (Radiomed Corp., 2000) after a 29-day review. Its family tree reaches back 2 generations to 1987. 23 later devices descend from it.
- Decided
- Dec 5, 2001
- Review
- 29 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K874787 (1987). 3 ancestors in all. 23 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK874787 Modified Palladium Seed Model 100Theragenics Corp. · 1987
- 1 generation backK001070 Radiomed SourceRadiomed Corp. · 2000
- This deviceK013660 GenetraRadiomed Corporation · 2001
- Descendant · cites it directly · 21 of its ownK022326 Radiomed MarkerRadiomed Corporation · 2003
- Descendant · 2 generations on · 20 of its ownK031206 Radiomed Soft Tissue MarkerRadiomed Corp. · 2003
- Descendant · 3 generations on · 11 of its ownK070305 Pre-Loaded VisicoilRadiomed Corporation · 2007
- Descendant · 3 generations on · 9 of its ownK080726 Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2008
- Descendant · 4 generations on · 6 of its ownK102373 Calypso System with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2010
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K022326Radiomed MarkerRadiomed Corporation · 2003 · cites it directly21descendants
- K031206Radiomed Soft Tissue MarkerRadiomed Corp. · 2003 · 2 generations on20descendants
- K070305Pre-Loaded VisicoilRadiomed Corporation · 2007 · 3 generations on11descendants
- K080726Calypso 4D Localization SystemCalypso Medical Technologies, Inc. · 2008 · 3 generations on9descendants
- K102373Calypso System with Dynamic Edge GatingCalypso Medical Technologies, Inc. · 2010 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K874787 | Modified Palladium Seed Model 100 | Theragenics Corp. | 1987 | — |
| −1 | K001070 | Radiomed Source | Radiomed Corp. | 2000 | — |
| 0 (this device) | K013660 | Genetra | Radiomed Corporation | 2001 | — |
| +1 | K022326 | Radiomed Marker | Radiomed Corporation | 2003 | — |
| +2 | K031206 | Radiomed Soft Tissue Marker | Radiomed Corp. | 2003 | — |
| +3 | K070305 | Pre-Loaded Visicoil | Radiomed Corporation | 2007 | — |
| +3 | K080726 | Calypso 4D Localization System | Calypso Medical Technologies, Inc. | 2008 | — |
| +4 | K102373 | Calypso System with Dynamic Edge Gating | Calypso Medical Technologies, Inc. | 2010 | — |
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 |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2014 | 2 | 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? (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 |
|---|---|---|---|
| * | K001070 | Radiomed SourceSummary page 1…urce Classification Name: Brachytherapy Radionuclide 3. Identification of Predicate or Legally Marketed Device The predicate device for GENETRA™ is the RadioMed™ Source K001070. 4. Device Description GENETRA™ utilizes Pd-103 as the radionuclide for brachytherapy. GENETRA ™ exists in the form of a coiled… | 2000 |
What descends from it? (23)
See all 232 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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 12.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K022326 (Radiomed Corporation, 2003) has gone furthest, with 21 descendants of its own.
- 1 other device also cites its predicate K001070.
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?
GENETRA™ with activities from 0.1 to 5.0 mCi per centimeter length is indicated for temporary or permanent interstitial implantation or surface application to treat selected localized tumors. They can be used either as the primary treatment or as treatment for residual disease after excision of primary or recurrent tumors. GENETRA™ 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 tumors are commonly treated.
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/K013660 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013660: Genetra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013660
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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