KXKClass II

Source, Brachytherapy, Radionuclide

21 CFR 892.5730 / Radiology

KXK is the FDA product code for Source, Brachytherapy, Radionuclide, a class II device type, regulated under 21 CFR 892.5730. As of 2026-09-10, FDA records hold 151 510(k) clearances under this code, the most recent dated 2025-12-05, and 7 recalls.

Classification record

Product code: KXK
Device name: Source, Brachytherapy, Radionuclide
Regulation: 21 CFR 892.5730
Device class: Class II
Review panel: Radiology
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 151
Ingested recalls: 7

Clearances, product code KXK

By decision year

151 clearances under product code KXK with a decision year between 1980 and 2025, 2000 the highest year at 15.

Show the numbers

510(k) clearances under FDA product code KXK by decision year
Year	Clearances
1980	1
1985	3
1990	4
1991	4
1992	4
1993	4
1994	2
1995	1
1997	2
1998	1
1999	10
2000	15
2001	10
2002	7
2003	13
2004	8
2005	5
2006	6
2007	5
2008	1
2009	7
2010	1
2011	5
2012	3
2013	3
2014	8
2015	2
2016	4
2017	2
2018	1
2019	2
2020	3
2022	1
2023	1
2025	2

Applicants with the most clearances

Product code KXK

Applicants holding the most 510(k) clearances under product code KXK
Applicant	Clearances
Cp Medical	6
Implant Sciences Corp.	6
Isoaid, L.L.C.	6
Source Production and Equipment Co., Inc.	6
Worldwide Medical Technologies, LLC	6
C.R. Bard Inc	5
Isoray Medical, Inc.	5
Medi-Physics Inc. dba Nycomed Amersham Imaging	4
Syncor Pharmaceuticals, Inc.	4
Theragenics Corp.	4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 25 companies shown, in name order