KXK · Class II · 21 CFR 892.5730

FDA Product Code KXK: Source, Brachytherapy, Radionuclide

Leading manufacturers include C.R. Bard, Inc., Gt Medical Technologies and Isoray Medical, Inc..

151
Total
151
Cleared
131d
Avg days
1980
Since
Stable submission activity - 2 submissions in the last 2 years
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 May 02, 2014
BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS
K140856
C.R. Bard, Inc.
Radiology · 29d
Cleared Dec 23, 2009
RADIONUCLIDE BRACHYTHERAPY SOURCE
K093663
C.R. Bard, Inc.
Radiology · 28d
Cleared Apr 19, 2006
PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE
K060636
C.R. Bard, Inc.
Radiology · 40d
Cleared Feb 02, 2005
BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS
K043246
C.R. Bard, Inc.
Radiology · 71d
Cleared Jul 02, 2004
SOURCELINK
K041576
C.R. Bard, Inc.
Radiology · 21d
Cleared Dec 18, 1980
3M I-125 SEEDS IN ABSORBABLE CARRIER
K801748
3M Company
Radiology · 143d

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 remained relatively stable over the observed period, with 2 submissions in the last 24 months.

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 →