Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JAQ — Predicate Candidate Screening
208 FDA 510(k) clearances under this product code; the 50 most recent screened below.
99 daysmedian FDA review time
266 days90th percentile
208clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K262383 | LumenCare Azure | Nucletron B.V. | 2026-07-24 | 11 | 0 |
| K252717 | MAASTRO Rectal Applicator Set | Varian Medical Systems | 2026-05-20 | 265 | 0 |
| K251037 | Rectal Applicator | Nucletron B.V. | 2025-12-19 | 260 | 0 |
| K252884 | Guided Aarhus Applicator Set | Varian Medical Systems | 2025-11-19 | 70 | 0 |
| K250299 | CT/ MR Tandem and Ovoid Set | Varian Medical Systems, Inc. | 2025-05-09 | 98 | 0 |
| K250289 | Intracavitary/Interstitial System | Varian Medical Systems | 2025-04-25 | 84 | 0 |
| K243939 | Titanium Flexible Geometry FSD Applicator Set (GM11013400) | Varian Medical Systems, Inc. | 2025-03-03 | 73 | 0 |
| K241764 | Mould Probe MR Safe | Varian Medical Systems, Inc. | 2025-01-10 | 204 | 0 |
| K242961 | Intraluminal Applicator Set | Varian Medical Systems | 2024-11-26 | 62 | 0 |
| K243045 | “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001 | Braxx Biotech Co., Ltd. | 2024-11-19 | 53 | 0 |
| K241853 | Titanium Fletcher-Style Applicator Set Defined Geometry; Smi | Varian Medical Systems, Inc. | 2024-11-07 | 133 | 0 |
| K241965 | Catheter Surface Flap Applicator Set (GM11011830) | Varian Medical Systems | 2024-10-29 | 118 | 0 |
| K241386 | Heyman Packing Applicator Set (GM11004580) | Varian Medical Systems, Inc. | 2024-08-30 | 107 | 0 |
| K233628 | AOS Interstitial Templates, Needles, and Accessories | Alpha-Omega Services, Inc. | 2024-07-10 | 240 | 0 |
| K233626 | AOS Marker Seeds (SMG0242-025) | Alpha-Omega Services, Inc. | 2024-07-02 | 232 | 0 |
| K240495 | Flexible Fixation Device for Gynecological Applicators (GM11 | Varian Medical Systems, Inc. | 2024-05-09 | 79 | 0 |
| K232623 | Universal Endometrial Applicator Set (GM11009840) | Varian Medical Systems, Inc. | 2024-04-09 | 224 | 0 |
| K232949 | Kelowna GYN and Crook Prostate Templates | Varian Medical Systems, Inc. | 2024-02-01 | 134 | 0 |
| K230155 | Mick Valencia Applicator Set | Mick Radio-Nuclear Instruments, Inc. | 2023-08-30 | 223 | 0 |
| K222775 | Aarhus Applicator Set | Varian Medical Systems, Inc. | 2023-03-13 | 180 | 0 |
| K221797 | BRAVOS Afterloader Family: BRAVOS Afterloader System, Transf | Varian Medical Systems, Inc. | 2022-09-14 | 85 | 0 |
| K193240 | Universal Cylinder Applicator Family | Varian Medical Systems, Inc. | 2020-08-17 | 266 | 0 |
| K201272 | Geneva | Nucletron B.V. | 2020-07-16 | 65 | 1 |
| K201279 | ASSISTO Universal Applicator Clamping Device | Geomed Medizin-Technik GmbH & Co. KG | 2020-07-10 | 58 | 0 |
| K200221 | CT F/S/D Compatible Applicators (Fletcher), HDR Compatible T | Mick Radio-Nuclear Instruments, Inc. | 2020-02-28 | 30 | 0 |
| K191580 | BRAVOS Afterloader System, Transfer Guide Tubes, Length Asse | Varian Medical Systems, Inc. | 2019-07-08 | 24 | 0 |
| K183332 | “BRAXX” Esophageal Brachytherapy Applicator | Braxx Biotech Co., Ltd. | 2019-04-16 | 134 | 0 |
| K172533 | GM Implant Tubes, Length Cutting Gauge | Varian Medical Systems, Inc. | 2018-10-22 | 426 | 0 |
| K181903 | BRAVOS Afterloader Family: BRAVOS Afterloader System, Transf | Varian Medical Systems, Inc. | 2018-10-03 | 79 | 0 |
| K172675 | Varian Cervical Sleeves | Varian Medical Systems, Inc. | 2018-05-16 | 253 | 0 |
| K180069 | HDR MRI Lumen Marker | C4 Imaging, LLC | 2018-04-27 | 108 | 0 |
| K162499 | Best Instruminal Applicator | Best Medical International, Inc. | 2018-04-13 | 583 | 0 |
| K172611 | Universal Cylinder Applicator Family, Universal Segmented Cy | Varian Medical Systems, Inc. | 2018-03-21 | 202 | 0 |
| K171631 | Standard Catheter Set | Varian Medical Systems, Inc. | 2018-02-09 | 252 | 0 |
| K162533 | Kelowna GYN and Crook Prostate Templates | Varian Medical Systems, Inc. | 2017-08-31 | 356 | 0 |
| K170203 | System, Applicator, Radionuclide, Remote Controlled | Kobold, LLC | 2017-06-01 | 129 | 0 |
| K162615 | Mould Applicator Set | Varian Medical Systems, Inc. | 2017-03-24 | 186 | 0 |
| K160815 | Interstitial Needles | Varian Medical Systems, Inc. | 2017-03-10 | 351 | 0 |
| K162018 | Surface Applicator Set | Varian Medical Systems, Inc. | 2017-02-28 | 229 | 0 |
| K160610 | Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobol | Kobold, LLC | 2017-02-13 | 347 | 0 |
| K161688 | Advanced Gynecological Applicator | Nucletron B.V. | 2017-01-27 | 221 | 1 |
| K160045 | Heyman Packing Applicator Set | Varian Medical Systems, Inc. | 2016-11-17 | 314 | 0 |
| K161540 | Advanced Breast Template System | Varian Medical Systems, Inc. | 2016-10-20 | 139 | 0 |
| K161576 | Esophagus Bougie Set | Varian Medical Systems, Inc. | 2016-10-02 | 117 | 0 |
| K160516 | Universal Cylinder Applicator Family, Universal Segmented Cy | Varian Medical Systems, Inc. | 2016-08-10 | 168 | 0 |
| K150979 | CT/MR Compatible M.A.C. Interstitial GYN Template | Mick Radio-Nuclear Instruments, Inc. | 2016-05-31 | 414 | 0 |
| K160021 | Varian Sterilization Boxes | Varian Medical Systems, Inc. | 2016-04-13 | 99 | 0 |
| K151022 | Intraluminal Applicator Set | Varian Medical Systems, Inc. | 2015-12-17 | 245 | 0 |
| K152018 | Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak | Varian Medical Systems, Inc. | 2015-09-11 | 52 | 0 |
| K151657 | Shielded Applicator Set, Cervical Stop | Varian Medical Systems, Inc. | 2015-08-07 | 49 | 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