KXK · Class II · 21 CFR 892.5730

FDA Product Code KXK: Source, Brachytherapy, Radionuclide

Leading manufacturers include Implant Sciences Corp., Cp Medical and Worldwide Medical Technologies, LLC.

151
Total
151
Cleared
131d
Avg days
1980
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 218d recently vs 129d historically

FDA 510(k) Cleared Source, Brachytherapy, Radionuclide Devices (Product Code KXK)

151 devices
1–24 of 151
Cleared Dec 05, 2025
OncoPatch
K252296
Oncopatch, Inc.
Radiology · 135d
Cleared Jul 15, 2025
IsoSphere
K242818
Isoaid, LLC
Radiology · 300d
Cleared Jan 11, 2023
RadianceTx Radionuclide Brachytherapy Source
K223465
Radiance Therapeutics, Inc.
Radiology · 55d
Cleared Nov 09, 2022
GammaTile
K221539
Gt Medical Technologies
Radiology · 166d
Cleared Dec 31, 2020
Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles
K202267
Isoray Medical, Inc.
Radiology · 142d
Cleared May 29, 2020
LV Liberty Vision Model 1 90Yttrium Brachytherapy Source
K193602
Lv Liberty Vision Corporation
Radiology · 158d
Cleared Jan 23, 2020
GammaTile
K190839
Gt Medical Technologies
Radiology · 297d
Cleared Sep 20, 2019
CivaDerm
K191324
Civatech Oncology, Inc.
Radiology · 127d
Cleared Mar 13, 2019
GammaTile
K190296
Gt Medical Technologies
Radiology · 30d
Cleared Jul 06, 2018
GammaTile
K180515
Isoray Medical, Inc.
Radiology · 129d
Cleared Aug 25, 2017
Sirius MRI Marker NS
K171487
C4 Imaging, LLC
Radiology · 95d
Cleared Mar 15, 2017
LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source
K163572
Lv Liberty Vision Corp.
Radiology · 86d
Cleared Dec 15, 2016
SMD-Sr90-DA Radionuclide Brachytherapy Source
K163206
Salutaris Medical Devices, Inc.
Radiology · 30d
Cleared Nov 04, 2016
Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source
K162573
Source Production and Equipment Co., Inc.
Radiology · 50d
Cleared Aug 17, 2016
SPEC Model M23
K161396
Source Production and Equipment Co., Inc.
Radiology · 90d
Cleared Jul 06, 2016
SPEC Model M13
K161395
Source Production and Equipment Co., Inc.
Radiology · 48d
Cleared Jun 19, 2015
SPEC Model M16
K150895
Source Production and Equipment Co., Inc.
Radiology · 78d
Cleared May 08, 2015
VariSeed 9.0
K150636
Varian Medical Systems, Inc.
Radiology · 58d
Cleared Dec 19, 2014
SMD Sr90-1 Radionuclide Brachytherapy Source
K142701
Salutaris Medical Devices, Inc.
Radiology · 88d
Cleared Dec 05, 2014
I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE]
K141701
Isoaid, LLC
Radiology · 164d
Cleared Nov 21, 2014
Lesion-Loc Iodine I-125 Seed/Needle
K142668
Intramedical Imaging, LLC
Radiology · 63d
Cleared Nov 12, 2014
ANT MODEL 1
K141038
Advanced Nuclide Technologies, LLC
Radiology · 204d
Cleared Aug 29, 2014
CIVA SHEET PD-103
K140490
Civatech Oncology, Inc.
Radiology · 183d
Cleared Jul 02, 2014
ISOSEED
K140849
Eckert & Ziegler Bebig GmbH
Radiology · 90d

About Product Code KXK - Regulatory Context

510(k) Submission Activity

151 total 510(k) submissions under product code KXK since 1980, with 151 receiving FDA clearance (average review time: 131 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - KXK Product Code

Recent submissions under KXK have taken an average of 218 days to reach a decision - up from 129 days historically. Manufacturers should account for longer review timelines in current project planning.

KXK devices are reviewed by the Radiology panel. Browse all Radiology devices →