510(k) · Cleared

Cleared

Brachysource Seed Implants with Sourcecap Bioabsorbable Caps

K140856510(k) SpecialCleared May 2, 201429-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

C.R. Bard, Inc. · KXK Source, Brachytherapy, Radionuclide

Cleared on May 2, 2014 as substantially equivalent to K093663 (C.R. Bard, Inc., 2009) after a 29-day review. Its family tree reaches back 2 generations to 2005.

Decided: May 2, 2014
Review: 29 days
Class: Class II
Product code: KXK
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K043246 (2005). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK043246 Brachysource Brachytherapy Seed ImplantsC.R. Bard, Inc. · 2005 · Recalled
1 generation backK093663 Radionuclide Brachytherapy SourceC.R. Bard, Inc. · 2009 · Recalled
This deviceK140856 Brachysource Seed Implants with Sourcecap Bioabsorbable CapsC.R. Bard, Inc. · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K043246	Brachysource Brachytherapy Seed Implants	C.R. Bard, Inc.	2005	1
−1	K093663	Radionuclide Brachytherapy Source	C.R. Bard, Inc.	2009	1
0 (this device)	K140856	Brachysource Seed Implants with Sourcecap Bioabsorbable Caps	C.R. Bard, Inc.	2014	—

FIG. 1 — Lineage of K140856, 2005–2014Source: 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
*	K093663	Radionuclide Brachytherapy Source Summary page 1 …n: 11 Product Code: KXK Legaily marketed device to which substantial equivalence is claimed: Brachy~ourceO Brachytherapy Seed Implants, K093663 Device Description BrachySourceO Seed Implants with SourceCapTM Bioabsorbable Caps consist of a Seed implant with bioabsorbable…	C.R. Bard, Inc.	2009	1
†	K041576	Sourcelink	C.R. Bard, Inc.	2004	—

What descends from it?

No later submission names this one as a predicate yet.

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 9 years and passes through 1 company; a new generation was cleared every 4.9 years on median.
2 of the 2 ancestors have a recall of any class.

How does its category compare?

All KXK devices

KXK Source, Brachytherapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

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?

BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps are indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps may be used in superficial, intra-abdominal and intra-thoracic locations. BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps are indicated to treat residual tumors following completion of a course of external radiation therapy and for recurrent tumors.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K140856 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140856: Brachysource Seed Implants with Sourcecap Bioabsorbable Caps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140856

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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