510(k) · Cleared

Cleared

CP-Sleeve

K013975510(k) TraditionalCleared Feb 22, 200281-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 Feb 22, 2002 as substantially equivalent to K940632 (Medi-Physics Inc. Dba Nycomed Amersham Imaging, 1994) and 2 other predicates after an 81-day review. Its family tree reaches back 1 generation to 1994. 6 later devices descend from it.

Decided: Feb 22, 2002
Review: 81 days
Class: Class II
Product code: KXK
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K940632 (1994). 3 ancestors in all. 6 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK940632 I-125 Rapid StrandMedi-Physics Inc. Dba Nycomed Amersham Imaging · 1994
This deviceK013975 CP-SleeveCp 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

2004high 1 (2004) · low 0 (2005)2026

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
−1	K940632	I-125 Rapid Strand	Medi-Physics Inc. Dba Nycomed Amersham Imaging	1994	—
0 (this device)	K013975	CP-Sleeve	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	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	2	0

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

FIG. 1 — Lineage of K013975, 1994–2017Source: 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? (3)

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
*	K940632	I-125 Rapid Strand Summary page 1 …to) Date Prepared: November 29, 2001 Predicate Device: The predicate device to the CP Medical CP-SLEEVE accessory device is the 1-125 Rapid Strand ‘s accessory Sleeve (K940632 and K010821) for the brachytherapy application system and the CP Medical Absorbable Seeding Spacer component (K010621) Device D…	Medi-Physics Inc. Dba Nycomed Amersham Imaging	1994	—
*	K010821	Echoseed/Iodine-125 Seeds, Model 6733 Summary page 1 …epared: November 29, 2001 Predicate Device: The predicate device to the CP Medical CP-SLEEVE accessory device is the 1-125 Rapid Strand ‘s accessory Sleeve (K940632 and K010821) for the brachytherapy application system and the CP Medical Absorbable Seeding Spacer component (K010621) Device Description:…	Medi-Physics Inc. Dba Nycomed Amersham Imaging	2001	—
*	K010621	Accu-Space Absorbable Seeding Spacers Summary page 1 …ice is the 1-125 Rapid Strand ‘s accessory Sleeve (K940632 and K010821) for the brachytherapy application system and the CP Medical Absorbable Seeding Spacer component (K010621) Device Description: The CP Medical CP-SLEEVE consists of absorbable polymer or copolymer material, braided and non-braided, whi…	Cp Medical	2001	—

Also cleared against K940632: 6 other devices →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K034062	CP Sleeve and River Sleeve	Cp Medical	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?

None of the 3 ancestors has a recall.
Of its descendants, K034062 (Cp Medical, 2004) has gone furthest, with 5 descendants of its own.
6 other devices also cite its predicate K940632.

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 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 CP-Sleeve is 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/K013975 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013975: CP-Sleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013975

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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