510(k) · Cleared
ClearedMri Marker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C4 Imaging, LLC · KXK Source, Brachytherapy, Radionuclide
Cleared on Nov 20, 2013 as substantially equivalent to K103449 (Riverpoint Medical, 2011) and 3 other predicates after a 163-day review. Its family tree reaches back 5 generations to 2001. 1 later device descends from it.
- Decided
- Nov 20, 2013
- Review
- 163 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K010621 (2001). 13 ancestors in all, the oldest K940632 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK010621 Accu-Space Absorbable Seeding SpacersCp Medical · 2001
- 4 generations backK013964 Modification to Accu-Space Plain Gut Absorbable Seeding SpacersCp Medical · 2002
- 3 generations backK021311 Synthetic Absorbable Seeding Spacers Made of Polydioxanone MaterialCp Medical · 2002
- 2 generations backK034062 CP Sleeve and River SleeveCp Medical · 2004
- 1 generation backK103449 Brachytherapy Needles, RP Sleeve, RP Brachy-Spacer, Gold MakersRiverpoint Medical · 2011
- This deviceK131689 Mri MarkerC4 Imaging, LLC · 2013
- Descendant · cites it directly · 0 of its ownK171487 Sirius MRI Marker NSC4 Imaging, LLC · 2017
Most influential descendants
Showing 1 of 1 · See all- K171487Sirius MRI Marker NSC4 Imaging, LLC · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010621 | Accu-Space Absorbable Seeding Spacers | Cp Medical | 2001 | — |
| −4 | K013964 | Modification to Accu-Space Plain Gut Absorbable Seeding Spacers | Cp Medical | 2002 | — |
| −3 | K021311 | Synthetic Absorbable Seeding Spacers Made of Polydioxanone Material | Cp Medical | 2002 | — |
| −2 | K034062 | CP Sleeve and River Sleeve | Cp Medical | 2004 | — |
| −1 | K103449 | Brachytherapy Needles, RP Sleeve, RP Brachy-Spacer, Gold Makers | Riverpoint Medical | 2011 | — |
| 0 (this device) | K131689 | Mri Marker | C4 Imaging, LLC | 2013 | — |
| +1 | K171487 | Sirius MRI Marker NS | C4 Imaging, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (4)
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 |
|---|---|---|---|
| * | K103449 | Brachytherapy Needles, RP Sleeve, RP Brachy-Spacer, Gold MakersSummary page 2…02-00 1 Predicate Devices R13 Spacer K 103449 Riverpoint Medical Worldwide Medical Technologies Anchor K083274 lBiocompatibles Marker… | 2011 |
| * | K083274 | Worldwide Medical Technologies Anchor Marker, Marker Strand and MarkerSummary page 2…= Predicate Devices R13 Spacer K 103449 Riverpoint Medical Worldwide Medical Technologies Anchor K083274 lBiocompatibles Marker Accu-SpaceM Absorbable Seeding Spacer K010621 Cl1 Medical Optis… | 2009 |
| * | K010621 | Accu-Space Absorbable Seeding SpacersSummary page 2…t Medical Worldwide Medical Technologies Anchor K083274 lBiocompatibles Marker Accu-SpaceM Absorbable Seeding Spacer K010621 Cl1 Medical Optisource103 K040766 113t s.a. Device IDescription C4… | 2001 |
| * | K040766 | Optisource, Model 1032PSummary page 2…iocompatibles Marker Accu-SpaceM Absorbable Seeding Spacer K010621 Cl1 Medical Optisource103 K040766 113t s.a. Device IDescription C4 Imaging's MRI MarkerTM consists of a scaled polyether ether ketone (PEEK) pol… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171487 | Sirius MRI Marker NS | 2017 | 0 |
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 12 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K171487 (C4 Imaging, LLC, 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K103449.
How does its category compare?
All KXK devicesKXK Source, Brachytherapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
The MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy sources containing one of the following isotopes: Iodine 125 (125I), Palladium 103 (103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131689 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131689: Mri Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131689
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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