510(k) · Cleared
ClearedSynthetic Absorbable Seeding Spacers Made of Polydioxanone Material
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 Jul 13, 2002 as substantially equivalent to K010621 (Cp Medical, 2001) and 1 other predicate after a 79-day review. Its family tree reaches back 2 generations to 2001. 6 later devices descend from it.
- Decided
- Jul 13, 2002
- Review
- 79 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K010621 (2001). 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK010621 Accu-Space Absorbable Seeding SpacersCp Medical · 2001
- 1 generation backK013964 Modification to Accu-Space Plain Gut Absorbable Seeding SpacersCp Medical · 2002
- This deviceK021311 Synthetic Absorbable Seeding Spacers Made of Polydioxanone MaterialCp Medical · 2002
- Descendant · cites it directly · 5 of its ownK034062 CP Sleeve and River SleeveCp Medical · 2004
- Descendant · 2 generations on · 3 of its ownK103449 Brachytherapy Needles, RP Sleeve, RP Brachy-Spacer, Gold MakersRiverpoint Medical · 2011
- Descendant · 3 generations on · 1 of its ownK131689 Mri MarkerC4 Imaging, LLC · 2013
- Descendant · 4 generations on · 0 of its ownK171487 Sirius MRI Marker NSC4 Imaging, LLC · 2017
- Descendant · 3 generations on · 0 of its ownK120859 Pre-Loaded Gold Visicoil CK MarkerRadiomed Corporation · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K034062CP Sleeve and River SleeveCp Medical · 2004 · cites it directly5descendants
- K103449Brachytherapy Needles, RP Sleeve, RP Brachy-Spacer, Gold MakersRiverpoint Medical · 2011 · 2 generations on3descendants
- K131689Mri MarkerC4 Imaging, LLC · 2013 · 3 generations on1descendant
- K171487Sirius MRI Marker NSC4 Imaging, LLC · 2017 · 4 generations on0descendants
- K120859Pre-Loaded Gold Visicoil CK MarkerRadiomed Corporation · 2012 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010621 | Accu-Space Absorbable Seeding Spacers | Cp Medical | 2001 | — |
| −1 | K013964 | Modification to Accu-Space Plain Gut Absorbable Seeding Spacers | Cp Medical | 2002 | — |
| 0 (this device) | K021311 | Synthetic Absorbable Seeding Spacers Made of Polydioxanone Material | Cp Medical | 2002 | — |
| +1 | K034062 | CP Sleeve and River Sleeve | Cp Medical | 2004 | — |
| +2 | K103449 | Brachytherapy Needles, RP Sleeve, RP Brachy-Spacer, Gold Makers | Riverpoint Medical | 2011 | — |
| +3 | K131689 | Mri Marker | C4 Imaging, LLC | 2013 | — |
| +4 | K171487 | Sirius MRI Marker NS | C4 Imaging, LLC | 2017 | — |
| +3 | K120859 | Pre-Loaded Gold Visicoil CK Marker | Radiomed Corporation | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 |
|---|---|---|---|
| * | K010621 | Accu-Space Absorbable Seeding Spacers | 2001 |
| * | K013964 | Modification to Accu-Space Plain Gut Absorbable Seeding SpacersSummary page 1…he CP Medical Polydioxanone Synthetic Absorbable Seeding Spacers is t h e C P M e d i c a l device, a b s o r b a b l e seedivg s p a c e r s [KO10621 a n d K0139641. Device Description: The CP Medical Polydioxanone Synthetic Absorbable Seeding, S p a c e r consists of absorbable… | 2002 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K034062 | CP Sleeve and River Sleeve | 2004 | 5 |
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?
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 seeding spacers made of polydioxanone material are indicated for use in brachytherapy, 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/K021311 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021311: Synthetic Absorbable Seeding Spacers Made of Polydioxanone Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021311
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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