510(k) · Cleared
ClearedPre-Loaded Gold Visicoil CK Marker
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 Apr 19, 2012 as substantially equivalent to K070305 (Radiomed Corporation, 2007) and 1 other predicate after a 28-day review. Its family tree reaches back 6 generations to 1987.
- Decided
- Apr 19, 2012
- Review
- 28 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K874787 (1987). 21 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK874787 Modified Palladium Seed Model 100Theragenics Corp. · 1987
- 5 generations backK001070 Radiomed SourceRadiomed Corp. · 2000
- 4 generations backK013660 GenetraRadiomed Corporation · 2001
- 3 generations backK022326 Radiomed MarkerRadiomed Corporation · 2003
- 2 generations backK031206 Radiomed Soft Tissue MarkerRadiomed Corp. · 2003
- 1 generation backK070305 Pre-Loaded VisicoilRadiomed Corporation · 2007
- This deviceK120859 Pre-Loaded Gold Visicoil CK MarkerRadiomed Corporation · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K874787 | Modified Palladium Seed Model 100 | Theragenics Corp. | 1987 | — |
| −5 | K001070 | Radiomed Source | Radiomed Corp. | 2000 | — |
| −4 | K013660 | Genetra | Radiomed Corporation | 2001 | — |
| −3 | K022326 | Radiomed Marker | Radiomed Corporation | 2003 | — |
| −2 | K031206 | Radiomed Soft Tissue Marker | Radiomed Corp. | 2003 | — |
| −1 | K070305 | Pre-Loaded Visicoil | Radiomed Corporation | 2007 | — |
| 0 (this device) | K120859 | Pre-Loaded Gold Visicoil CK Marker | Radiomed Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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? (2)
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 |
|---|---|---|---|
| * | K070305 | Pre-Loaded VisicoilSummary page 1…on of Predicate or Legally Marketed Device The predicate devices for RadioMed- Soft Tissue Marker are: 1. Visicojilh Pre Loaded Visicoil Marker (K070305) 2. Brachy Needles/Spacer/Sleeve/Marker (Kl03449) 4. Device Description The Pre-Loaded CK Visicoil a steri… | 2007 |
| * | K103449 | Brachytherapy Needles, RP Sleeve, RP Brachy-Spacer, Gold MakersSummary page 2…ice: Pre Loaded Visicoil Marker 510(k) Number: K 070305 Predicate Device: Brachy Needles/Sleeves/Spacers/Markers 510(k) Numnber: K103449 The design of the predicate Visicoil CK Marker is identical to the Pre-Loaded Marker as it is a gold metall… | 2011 |
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 25 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- None of the 21 ancestors has a recall.
- 5 other devices also cite its predicate K070305.
How does its category compare?
All KXK devicesKXK Source, Brachytherapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Pre-Loaded CK Visicoil Gold Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120859 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120859: Pre-Loaded Gold Visicoil CK Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120859
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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