Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
KXK — Predicate Candidate Screening
151 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
284 days90th percentile
151clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252296 | OncoPatch | Oncopatch, Inc. | 2025-12-05 | 135 | 0 |
| K242818 | IsoSphere | Isoaid, LLC | 2025-07-15 | 300 | 0 |
| K223465 | RadianceTx Radionuclide Brachytherapy Source | Radiance Therapeutics, Inc. | 2023-01-11 | 55 | 0 |
| K221539 | GammaTile | Gt Medical Technologies | 2022-11-09 | 166 | 0 |
| K202267 | Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI | Isoray Medical, Inc. | 2020-12-31 | 142 | 0 |
| K193602 | LV Liberty Vision Model 1 90Yttrium Brachytherapy Source | Lv Liberty Vision Corporation | 2020-05-29 | 158 | 0 |
| K190839 | GammaTile | Gt Medical Technologies | 2020-01-23 | 297 | 0 |
| K191324 | CivaDerm | Civatech Oncology, Inc. | 2019-09-20 | 127 | 0 |
| K190296 | GammaTile | Gt Medical Technologies | 2019-03-13 | 30 | 0 |
| K180515 | GammaTile | Isoray Medical, Inc. | 2018-07-06 | 129 | 0 |
| K171487 | Sirius MRI Marker NS | C4 Imaging, LLC | 2017-08-25 | 95 | 0 |
| K163572 | LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source | Lv Liberty Vision Corp. | 2017-03-15 | 86 | 0 |
| K163206 | SMD-Sr90-DA Radionuclide Brachytherapy Source | Salutaris Medical Devices, Inc. | 2016-12-15 | 30 | 0 |
| K162573 | Source Production & Equipment Co., Inc. Model M14 192Iridium | Source Production and Equipment Co., Inc. | 2016-11-04 | 50 | 0 |
| K161396 | SPEC Model M23 | Source Production and Equipment Co., Inc. | 2016-08-17 | 90 | 0 |
| K161395 | SPEC Model M13 | Source Production and Equipment Co., Inc. | 2016-07-06 | 48 | 0 |
| K150895 | SPEC Model M16 | Source Production and Equipment Co., Inc. | 2015-06-19 | 78 | 0 |
| K150636 | VariSeed 9.0 | Varian Medical Systems, Inc. | 2015-05-08 | 58 | 0 |
| K142701 | SMD Sr90-1 Radionuclide Brachytherapy Source | Salutaris Medical Devices, Inc. | 2014-12-19 | 88 | 0 |
| K141701 | I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE] | Isoaid, LLC | 2014-12-05 | 164 | 0 |
| K142668 | Lesion-Loc Iodine I-125 Seed/Needle | Intramedical Imaging, LLC | 2014-11-21 | 63 | 0 |
| K141038 | ANT MODEL 1 | Advanced Nuclide Technologies, LLC | 2014-11-12 | 204 | 0 |
| K140490 | CIVA SHEET PD-103 | Civatech Oncology, Inc. | 2014-08-29 | 183 | 0 |
| K140849 | ISOSEED | Eckert & Ziegler Bebig GmbH | 2014-07-02 | 90 | 0 |
| K140856 | BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS | C.R. Bard, Inc. | 2014-05-02 | 29 | 0 |
| K132969 | SPEC MODEL M15 | Source Production & Equipment Co., Inc. | 2014-01-02 | 101 | 0 |
| K132996 | CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE | Isoray, Inc. | 2013-12-17 | 84 | 0 |
| K131689 | MRI MARKER | C4 Imaging, LLC | 2013-11-20 | 163 | 0 |
| K122704 | BEST LOCALIZATION NEEDLE WITH I-125 SEED | Best Medical Intl. | 2013-01-09 | 127 | 0 |
| K122764 | RAPID STRAND RX | Medi-Physics, Inc. | 2012-12-28 | 109 | 0 |
| K113210 | ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT | Isoaid, LLC | 2012-08-10 | 283 | 0 |
| K120859 | PRE-LOADED GOLD VISICOIL CK MARKER | Radiomed Corporation | 2012-04-19 | 28 | 0 |
| K111979 | RADIOACTIVE SEED LOCALIZATION NEEDLE | Biocompatibles, Inc. | 2011-10-18 | 98 | 0 |
| K111931 | GLIASITE RTS | Isoray Medical, Inc. | 2011-08-05 | 28 | 0 |
| K102811 | AOS ORION IR-192 SOURCE CABLE | Alpha-Omega Services, Inc. | 2011-06-02 | 247 | 0 |
| K103449 | BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAK | Riverpoint Medical | 2011-02-25 | 94 | 0 |
| K103319 | I-SEED | Theragenics Corp. | 2011-01-03 | 52 | 0 |
| K100847 | SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 | Biocompatibles, Inc. | 2010-05-21 | 57 | 0 |
| K093663 | RADIONUCLIDE BRACHYTHERAPY SOURCE | C.R. Bard, Inc. | 2009-12-23 | 28 | 1 |
| K092522 | ACU007S | Oncology Systems, Inc. | 2009-11-20 | 94 | 0 |
| K091117 | ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IA | Isoaid, LLC | 2009-09-15 | 151 | 0 |
| K092458 | PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS- | Isoray Medical, Inc. | 2009-08-28 | 17 | 0 |
| K092136 | PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5 | Isoray Medical, Inc. | 2009-08-07 | 23 | 0 |
| K090366 | SPEC MODEL M-31 | Source Production & Equipment Co., Inc. | 2009-04-22 | 68 | 0 |
| K083274 | WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND | Biocompatibles, Inc. | 2009-01-08 | 63 | 0 |
| K082159 | CIVASTRING PD-103 | Civatech Oncology, Inc. | 2008-09-30 | 61 | 0 |
| K072296 | POIINT OF CARE STRANDING SYSTEM, MODE 1004-00 | Theragenics Corp. | 2007-09-26 | 40 | 1 |
| K071550 | PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS | Cp Medical | 2007-07-18 | 42 | 0 |
| K062825 | AOS MARKER SEEDS | Alpha-Omega Services, Inc. | 2007-05-22 | 244 | 0 |
| K070468 | IMPLANT SCIENCES CORP. MODEL HDR 4454 | Implant Sciences Corp. | 2007-03-23 | 35 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda