510(k) · Cleared

Cleared

Palladium-103 Seed Implant Kits -Multiple

K060636510(k) TraditionalCleared Apr 19, 200640-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 Apr 19, 2006 as substantially equivalent to K010283 (Theragenics Corp., 2001) and 1 other predicate after a 40-day review. Its family tree reaches back 1 generation to 2001.

Decided: Apr 19, 2006
Review: 40 days
Class: Class II
Product code: KXK
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K010283 (2001). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK010283 Theraseed (R) Palladium-103 Implant; Model 200Theragenics Corp. · 2001
This deviceK060636 Palladium-103 Seed Implant Kits -MultipleC.R. Bard, Inc. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010283	Theraseed (R) Palladium-103 Implant; Model 200	Theragenics Corp.	2001	—
0 (this device)	K060636	Palladium-103 Seed Implant Kits -Multiple	C.R. Bard, Inc.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0

FIG. 1 — Lineage of K060636, 2001–2006Source: 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? (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	Applicant	Decided	Recalls
*	K010283	Theraseed (R) Palladium-103 Implant; Model 200 Summary page 1 …d using TheraSeed® Palladium-103 Implants, which are produced and marketed commercially by Theragenics, Inc. under the 510(k) K010283. There is no change to the seeds produced by Theragenics and marketed under the name TheraSeed® Palladium-1…	Theragenics Corp.	2001	—
*	K043246	Brachysource Brachytherapy Seed Implants Summary page 1 …e packaged in various sterile and non-sterile configurations. These configurations are the same as the predicate described in K043246. The principles of operation and fundamental scientific technology have not changed.…	C.R. Bard, Inc.	2005	1

Also cleared against K010283: 5 other devices →

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?

1 of the 2 ancestors has a recall of any class.
5 other devices also cite its predicate K010283.

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?

TheraSeed® Palladium-103 Implants are indicated for tumors with any of the following

characteristics:

Localized,

Unresectable,

Low to moderate radiosensitivity.

The tumors may be of the following types:

Superficial;

Intrathoracic;

Intra-abdominal;

Lung, pancreas, prostate, head and neck;

Residual following external beam or excision of primary tumor;

Recurrent.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060636 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060636: Palladium-103 Seed Implant Kits -Multiple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060636

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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