510(k) · Cleared

Cleared

Modification to Accu-Space Plain Gut Absorbable Seeding Spacers

K013964510(k) SpecialCleared Jan 24, 200252-day reviewClass II21 CFR 892.5730

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cp Medical · KXK Source, Brachytherapy, Radionuclide

Cleared on Jan 24, 2002 as substantially equivalent to K010621 (Cp Medical, 2001) after a 52-day review. Its family tree reaches back 1 generation to 2001. 25 later devices descend from it.

Decided: Jan 24, 2002
Review: 52 days
Class: Class II
Product code: KXK
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K010621 (2001). 25 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK010621 Accu-Space Absorbable Seeding SpacersCp Medical · 2001
This deviceK013964 Modification to Accu-Space Plain Gut Absorbable Seeding SpacersCp Medical · 2002
Descendant · cites it directly · 17 of its ownK030594 I-125 Rapid Strand, Model 7000Amersham Health · 2003
Descendant · 2 generations on · 14 of its ownK040339 Brachytherapy Strand DeviceBebig Isotopen-Und Medizintechnik GmbH · 2004
Descendant · 3 generations on · 9 of its ownK043596 Theraload Custom Loaded Needles, Models 200 and 125.S06Theragenics Corp. · 2005
Descendant · 2 generations on · 7 of its ownK062384 Cesium-131 Strand, Strand Preload, Preload, S-CartridgeIsoray, Inc. · 2006
Descendant · cites it directly · 6 of its ownK021311 Synthetic Absorbable Seeding Spacers Made of Polydioxanone MaterialCp Medical · 2002

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2002high 4 (2006) · low 0 (2008)2026

Most influential descendants

Showing 5 of 25 · See all

K030594I-125 Rapid Strand, Model 7000Amersham Health · 2003 · cites it directly17descendants
K040339Brachytherapy Strand DeviceBebig Isotopen-Und Medizintechnik GmbH · 2004 · 2 generations on14descendants
K043596Theraload Custom Loaded Needles, Models 200 and 125.S06Theragenics Corp. · 2005 · 3 generations on9descendants
K062384Cesium-131 Strand, Strand Preload, Preload, S-CartridgeIsoray, Inc. · 2006 · 2 generations on7descendants
K021311Synthetic Absorbable Seeding Spacers Made of Polydioxanone MaterialCp Medical · 2002 · cites it directly6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010621	Accu-Space Absorbable Seeding Spacers	Cp Medical	2001	—
0 (this device)	K013964	Modification to Accu-Space Plain Gut Absorbable Seeding Spacers	Cp Medical	2002	—
+1	K030594	I-125 Rapid Strand, Model 7000	Amersham Health	2003	—
+2	K040339	Brachytherapy Strand Device	Bebig Isotopen-Und Medizintechnik GmbH	2004	—
+3	K043596	Theraload Custom Loaded Needles, Models 200 and 125.S06	Theragenics Corp.	2005	—
+2	K062384	Cesium-131 Strand, Strand Preload, Preload, S-Cartridge	Isoray, Inc.	2006	—
+1	K021311	Synthetic Absorbable Seeding Spacers Made of Polydioxanone Material	Cp Medical	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2004	2	0
2005	1	0
2006	4	0
2007	1	0
2009	3	0
2011	1	0
2012	3	0
2013	1	0
2017	1	0
2018	1	0
2019	1	0
2020	2	0
2022	1	0
2025	1	0

FIG. 1 — Lineage of K013964, 2001–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K010621	Accu-Space Absorbable Seeding Spacers Summary page 1 …epared: December 26, 2001 Predicate Device: The predicate device to the CP Medical BioSpacer or Accu- Space seeding spacer is the Accu-Space absorbable seeding spacers, K010621. Device Description: The CP Medical Accu-Space and BioSpacer consists of absorbable spacer material and is a small cylindrical c…	Cp Medical	2001	—

Also cleared against K010621: 4 other devices →

What descends from it? (25)

See all 25

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K030594	I-125 Rapid Strand, Model 7000	Amersham Health	2003	17
K021311	Synthetic Absorbable Seeding Spacers Made of Polydioxanone Material	Cp Medical	2002	6
K072296	Poiint of Care Stranding System, Mode 1004-00	Theragenics Corp.	2007	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?

Its one ancestor has no recall.
Of its descendants, K030594 (Amersham Health, 2003) has gone furthest, with 17 descendants of its own.
4 other devices also cite its predicate K010621.

How does its category compare?

All KXK devices

KXK Source, Brachytherapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KXK

2in 2025

2007high 8 (2014) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KXK

158in 2020

2007high 158 (2020) · low 42 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KXK

1in 2016

2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KXK

7in 2025

2007high 62 (2021) · low 0 (2010)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 absorbable seeding spacers are intended to be used to maintain a predetermined space between radionuclide seeds for the introduction of the seeds into the body during brachytherapy procedures. Seeding spacers are indicated for use in soft tissues or organ tissue but should not be used during cardiovascular or neurological procedures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K013964 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013964: Modification to Accu-Space Plain Gut Absorbable Seeding Spacers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013964

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026