510(k) · Cleared
ClearedCP Sleeve and River Sleeve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cp Medical · KXK Source, Brachytherapy, Radionuclide
Cleared on Jan 30, 2004 as substantially equivalent to K013975 (Cp Medical, 2002) and 1 other predicate after a 30-day review. Its family tree reaches back 3 generations to 2001. 5 later devices descend from it.
- Decided
- Jan 30, 2004
- Review
- 30 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K010621 (2001). 6 ancestors in all, the oldest K940632 (1994). 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK010621 Accu-Space Absorbable Seeding SpacersCp Medical · 2001
- 2 generations backK013964 Modification to Accu-Space Plain Gut Absorbable Seeding SpacersCp Medical · 2002
- 1 generation backK021311 Synthetic Absorbable Seeding Spacers Made of Polydioxanone MaterialCp Medical · 2002
- This deviceK034062 CP Sleeve and River SleeveCp Medical · 2004
- Descendant · cites it directly · 3 of its ownK103449 Brachytherapy Needles, RP Sleeve, RP Brachy-Spacer, Gold MakersRiverpoint Medical · 2011
- Descendant · 2 generations on · 1 of its ownK131689 Mri MarkerC4 Imaging, LLC · 2013
- Descendant · 3 generations on · 0 of its ownK171487 Sirius MRI Marker NSC4 Imaging, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK120859 Pre-Loaded Gold Visicoil CK MarkerRadiomed Corporation · 2012
- Descendant · cites it directly · 0 of its ownK061638 Best Strand and Best SpacerBest Medical International, Inc. · 2006
Most influential descendants
Showing 5 of 5 · See all- K103449Brachytherapy Needles, RP Sleeve, RP Brachy-Spacer, Gold MakersRiverpoint Medical · 2011 · cites it directly3descendants
- K131689Mri MarkerC4 Imaging, LLC · 2013 · 2 generations on1descendant
- K171487Sirius MRI Marker NSC4 Imaging, LLC · 2017 · 3 generations on0descendants
- K120859Pre-Loaded Gold Visicoil CK MarkerRadiomed Corporation · 2012 · 2 generations on0descendants
- K061638Best Strand and Best SpacerBest Medical International, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010621 | Accu-Space Absorbable Seeding Spacers | Cp Medical | 2001 | — |
| −2 | K013964 | Modification to Accu-Space Plain Gut Absorbable Seeding Spacers | Cp Medical | 2002 | — |
| −1 | K021311 | Synthetic Absorbable Seeding Spacers Made of Polydioxanone Material | Cp Medical | 2002 | — |
| 0 (this device) | K034062 | CP Sleeve and River Sleeve | Cp Medical | 2004 | — |
| +1 | K103449 | Brachytherapy Needles, RP Sleeve, RP Brachy-Spacer, Gold Makers | Riverpoint Medical | 2011 | — |
| +2 | K131689 | Mri Marker | C4 Imaging, LLC | 2013 | — |
| +3 | K171487 | Sirius MRI Marker NS | C4 Imaging, LLC | 2017 | — |
| +2 | K120859 | Pre-Loaded Gold Visicoil CK Marker | Radiomed Corporation | 2012 | — |
| +1 | K061638 | Best Strand and Best Spacer | Best Medical International, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K013975 | CP-SleeveSummary page 1…de (accessory to) Date Prepared: December 15, 2003 Predicate Device: The predicate device to the CP Medical CARRIER SLEEVE accessory device is the CP Medical, K01 3975, Placement Sleeve for Brachytherapy Procedures and the RIVER Medical Absorbable Seeding PDO Spacer component (K02131 1) Device D… | 2002 |
| * | K021311 | Synthetic Absorbable Seeding Spacers Made of Polydioxanone MaterialSummary page 1…CARRIER SLEEVE accessory device is the CP Medical, K01 3975, Placement Sleeve for Brachytherapy Procedures and the RIVER Medical Absorbable Seeding PDO Spacer component (K02131 1) Device Description: The CP Medical CARRIER SLEEVE consists of synthetic absorbable polymer or copolymer material, braided and n… | 2002 |
What descends from it? (5)
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 3 years and passes through 1 company; a new generation was cleared every 6 months on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K103449 (Riverpoint Medical, 2011) has gone furthest, with 3 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 | — |
What is it indicated for?
CP Medical's synthetic, absorbable placement sleeve accessory is intended to be
used with absorbable seeding spacers to facilitate the introduction of radionuclide seeds
and spacers into the body during Brachytherapy procedures. It is used to orient, hold,
carry and maintain spacing of the radionuclide seeds and the spacer component.
The Carrier Sleeve is indicated for use in soft tissues or organ tissue but should not be
used during cardiovascular or neurological procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K034062 · printed Nov 5, 2026
Cite this page
510(k) Report. “K034062: CP Sleeve and River Sleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K034062
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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