510(k) · Cleared
ClearedEchoseed/Iodine-125 Seeds, Model 6733
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medi-Physics Inc. Dba Nycomed Amersham Imaging · KXK Source, Brachytherapy, Radionuclide
Cleared on Apr 11, 2001 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Apr 11, 2001
- Review
- 23 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK010821 Echoseed/Iodine-125 Seeds, Model 6733Medi-Physics Inc. Dba Nycomed Amersham Imaging · 2001
- Descendant · cites it directly · 6 of its ownK013975 CP-SleeveCp Medical · 2002
- Descendant · 2 generations on · 5 of its ownK034062 CP Sleeve and River SleeveCp Medical · 2004
- Descendant · 3 generations on · 3 of its ownK103449 Brachytherapy Needles, RP Sleeve, RP Brachy-Spacer, Gold MakersRiverpoint Medical · 2011
- Descendant · 4 generations on · 1 of its ownK131689 Mri MarkerC4 Imaging, LLC · 2013
- Descendant · 5 generations on · 0 of its ownK171487 Sirius MRI Marker NSC4 Imaging, LLC · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K013975CP-SleeveCp Medical · 2002 · cites it directly6descendants
- K034062CP Sleeve and River SleeveCp Medical · 2004 · 2 generations on5descendants
- K103449Brachytherapy Needles, RP Sleeve, RP Brachy-Spacer, Gold MakersRiverpoint Medical · 2011 · 3 generations on3descendants
- K131689Mri MarkerC4 Imaging, LLC · 2013 · 4 generations on1descendant
- K171487Sirius MRI Marker NSC4 Imaging, LLC · 2017 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010821 | Echoseed/Iodine-125 Seeds, Model 6733 | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 2001 | — |
| +1 | K013975 | CP-Sleeve | Cp Medical | 2002 | — |
| +2 | K034062 | CP Sleeve and River Sleeve | Cp Medical | 2004 | — |
| +3 | K103449 | Brachytherapy Needles, RP Sleeve, RP Brachy-Spacer, Gold Makers | Riverpoint Medical | 2011 | — |
| +4 | K131689 | Mri Marker | C4 Imaging, LLC | 2013 | — |
| +5 | K171487 | Sirius MRI Marker NS | C4 Imaging, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
2 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?
- Of its descendants, K013975 (Cp Medical, 2002) has gone furthest, with 6 descendants of its own.
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 | — |
https://510kreport.com/device/K010821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010821: Echoseed/Iodine-125 Seeds, Model 6733.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010821
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026