510(k) · Cleared
ClearedBrachytherapy Needles, RP Sleeve, RP Brachy-Spacer, Gold Makers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Riverpoint Medical · KXK Source, Brachytherapy, Radionuclide
Cleared on Feb 25, 2011 as substantially equivalent to K071550 (Cp Medical, 2007) and 3 other predicates after a 94-day review. Its family tree reaches back 4 generations to 2001. 3 later devices descend from it.
- Decided
- Feb 25, 2011
- Review
- 94 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K010621 (2001). 10 ancestors in all, the oldest K940632 (1994). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK010621 Accu-Space Absorbable Seeding SpacersCp Medical · 2001
- 3 generations backK013964 Modification to Accu-Space Plain Gut Absorbable Seeding SpacersCp Medical · 2002
- 2 generations backK021311 Synthetic Absorbable Seeding Spacers Made of Polydioxanone MaterialCp Medical · 2002
- 1 generation backK034062 CP Sleeve and River SleeveCp Medical · 2004
- This deviceK103449 Brachytherapy Needles, RP Sleeve, RP Brachy-Spacer, Gold MakersRiverpoint Medical · 2011
- Descendant · cites it directly · 1 of its ownK131689 Mri MarkerC4 Imaging, LLC · 2013
- Descendant · 2 generations on · 0 of its ownK171487 Sirius MRI Marker NSC4 Imaging, LLC · 2017
- Descendant · cites it directly · 0 of its ownK120859 Pre-Loaded Gold Visicoil CK MarkerRadiomed Corporation · 2012
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010621 | Accu-Space Absorbable Seeding Spacers | Cp Medical | 2001 | — |
| −3 | K013964 | Modification to Accu-Space Plain Gut Absorbable Seeding Spacers | Cp Medical | 2002 | — |
| −2 | K021311 | Synthetic Absorbable Seeding Spacers Made of Polydioxanone Material | Cp Medical | 2002 | — |
| −1 | K034062 | CP Sleeve and River Sleeve | Cp Medical | 2004 | — |
| 0 (this device) | K103449 | Brachytherapy Needles, RP Sleeve, RP Brachy-Spacer, Gold Makers | Riverpoint Medical | 2011 | — |
| +1 | K131689 | Mri Marker | C4 Imaging, LLC | 2013 | — |
| +2 | K171487 | Sirius MRI Marker NS | C4 Imaging, LLC | 2017 | — |
| +1 | K120859 | Pre-Loaded Gold Visicoil CK Marker | Radiomed Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K071550 | Pre-Waxed Needles with Gold Fiduciary MarkersSummary page 2…KXK 4. Gold Markers: lYE Predicate Devices (applicable 510(k) number listed): 1. RP Brachytherapy Needles: CP Medical, K071550 2. RiP Sleeve: CP Medical, K034062 3. RP Spacer: CP Me… | 2007 |
| * | K034062 | CP Sleeve and River SleeveSummary page 2…pplicable 510(k) number listed): 1. RP Brachytherapy Needles: CP Medical, K071550 2. RiP Sleeve: CP Medical, K034062 3. RP Spacer: CP Medical, K010621 4. Gold Marker: Corte… | 2004 |
| * | K010621 | Accu-Space Absorbable Seeding SpacersSummary page 2…CP Medical, K071550 2. RiP Sleeve: CP Medical, K034062 3. RP Spacer: CP Medical, K010621 4. Gold Marker: Cortex Manufacturing, K(100267 Special Controls FDA Guidance "Guid… | 2001 |
| * | K100267 | Fleximarc, Model CM-0.9-2-10-GG-LSummary page 2…CP Medical, K034062 3. RP Spacer: CP Medical, K010621 4. Gold Marker: Cortex Manufacturing, K(100267 Special Controls FDA Guidance "Guidance for the Submission of Premarket Notifications for Photon- Emitting Bra… | 2010 |
What descends from it? (3)
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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K131689 (C4 Imaging, LLC, 2013) has gone furthest, with 1 descendant 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. 2011, 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?
RP Brachytherapy Needles are intended to be used for the placement of radionuclide seeds, and/or gold markers and/or Brachytherapy spacer/sleeve accessories during Brachytherapy or IMRT procedures. The RP Sleeve is intended to be used to facilitate the placement and containment of radioactive seeds and gold markers with or without spacers into the body during Brachytherapy or IMRT procedures. The RP Spacer is intended to be used during Brachytherapy or…
Read the full statement (127 words)
RP Brachytherapy Needles are intended to be used for the placement of radionuclide seeds, and/or gold markers and/or Brachytherapy spacer/sleeve accessories during Brachytherapy or IMRT procedures.
The RP Sleeve is intended to be used to facilitate the placement and containment of radioactive seeds and gold markers with or without spacers into the body during Brachytherapy or IMRT procedures.
The RP Spacer is intended to be used during Brachytherapy or IMRT procedures to facilitate the implant of radionuclide seeds or gold markers at predetermined intervals within the body tissue. Spacers are indicated for use in soft tissues or organ tissue, but not to be used during cardiovascular or neurological procedures.
RP Gold Markers are intended to provide localization information during Brachytherapy, IMRT, or other procedures involving radiation treatments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103449: Brachytherapy Needles, RP Sleeve, RP Brachy-Spacer, Gold Makers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103449
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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