Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NEY — Predicate Candidate Screening
68 FDA 510(k) clearances under this product code; the 50 most recent screened below.
150 daysmedian FDA review time
334 days90th percentile
68clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253771 | Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, | Nanjing Devin Medical Technology Co., Ltd. | 2026-03-02 | 96 | 0 |
| K252632 | Microwave Ablation Device | Nanjing Dewen Medical Technology Co., Ltd. | 2026-03-02 | 194 | 0 |
| K250718 | swiftPro System (SWF-SPS); Swift System (SWF-SYS) | Emblation Limited | 2025-08-08 | 151 | 0 |
| K241827 | Microwave Ablation Generator (KY-2000A, KY-2100A) | Canyon Medical, Inc. | 2024-09-26 | 94 | 0 |
| K241825 | Microwave Ablation Antennas | Canyon Medical, Inc. | 2024-09-20 | 88 | 0 |
| K240480 | IntelliBlate Microwave Ablation System Console (IB-CON); Int | Varian Medical Systems, Inc. | 2024-07-19 | 150 | 0 |
| K240784 | Temperature Sensor Probe (ABL-18TP20) | Varian Medical Systems, Inc. | 2024-05-29 | 69 | 0 |
| K240518 | swiftPro™ System | Emblation Limited | 2024-04-23 | 60 | 0 |
| K233838 | Emprint Ablation System with Thermosphere Technology (Overal | Medtronic, Inc. | 2024-03-28 | 115 | 0 |
| K233140 | Microwave Ablation Device (Exceed S10U); Sterile Microwave A | Hygea Medical Technology Co., Ltd. | 2024-01-31 | 126 | 0 |
| K231738 | NEUWAVE™ Microwave Ablation System and Accessories | Neuwave Medical, Inc. | 2023-11-16 | 155 | 0 |
| K232241 | Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608 | Betters(Suzhou) Medical Co., Ltd. | 2023-11-13 | 108 | 0 |
| K232240 | Microwave Ablation System (BD-GT) | Betters(Suzhou) Medical Co., Ltd. | 2023-11-13 | 108 | 0 |
| K223138 | AB1 Electrosurgical Instrument, Creo Electrosurgical System | Creo Medical, Ltd. | 2023-06-26 | 265 | 0 |
| K222388 | swiftPro System | Emblation , Ltd. | 2023-05-04 | 269 | 0 |
| K223581 | Solero Microwave Tissue Ablation (MTA) System and Accessorie | AngioDynamics, Inc. | 2023-03-27 | 116 | 0 |
| K221883 | Solero Microwave Tissue Ablation (MTA) System and Accessorie | AngioDynamics, Inc. | 2023-03-07 | 251 | 0 |
| K223272 | SurBlate Ablation System | Mima-Pro Scientific, Inc. | 2023-02-28 | 127 | 0 |
| K221672 | Creo Electrosurgical System with NP1 Instrument | Creo Medical, Ltd. | 2023-02-14 | 250 | 0 |
| K220472 | NEUWAVE Microwave Ablation System and Accessories | Neuwave Medical, Inc. | 2022-08-11 | 174 | 0 |
| K213067 | Solero Microwave Tissue Ablation (MTA) System and Accessorie | AngioDynamics, Inc. | 2021-12-03 | 71 | 0 |
| K201265 | Disposable Microwave Therapeutic Antennas | Nanjing Eco Microwave System Co., Ltd. | 2021-07-23 | 438 | 0 |
| K201262 | Microwave Therapeutic System | Nanjing Eco Microwave System Co., Ltd. | 2021-07-09 | 424 | 0 |
| K200298 | ABI Instrument, Creo Electrosurgical System | Creo Medical, Ltd. | 2021-01-05 | 334 | 0 |
| K203303 | Emprint SX Ablation Platform with Thermosphere Technology | Covidien, LLC | 2020-12-17 | 38 | 0 |
| K192406 | AveCure BT Microwave Ablation System | Medwaves, Inc. | 2020-11-25 | 448 | 0 |
| K200081 | NEUWAVE Microwave Ablation System and Accessories | Neuwave Medical, Inc. | 2020-11-13 | 303 | 0 |
| K200003 | NP1 Instrument, Creo Electrosurgical System | Creo Medical, Ltd. | 2020-10-28 | 300 | 0 |
| K200796 | Emprint Ablation System with Thermosphere Technology | Covidien, LLC | 2020-08-26 | 153 | 0 |
| K200061 | HEATfx Microwave Ablation System, HEATfx Microwave Ablation | Galil Medical, Inc. | 2020-07-09 | 178 | 0 |
| K193232 | Emprint Ablation System with Thermosphere Technology, Emprin | Covidien, LLC | 2020-02-13 | 80 | 0 |
| K183153 | Microwave Ablation System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2019-07-08 | 236 | 0 |
| K182250 | Solero MTA Cart, Solero MTA System, Solero microwave Tissue | AngioDynamics, Inc. | 2019-02-28 | 192 | 0 |
| K173756 | Certus 140 2.45GHz Ablation System | Neuwave Medical, Inc. | 2018-10-24 | 317 | 0 |
| K181941 | Swift System | Emblation , Ltd. | 2018-10-18 | 90 | 0 |
| K180396 | miraDry System | Miramar Labs, Inc. | 2018-03-15 | 30 | 0 |
| K171358 | Emprint SX Ablation Platform and Accessories | Coviden, LLC | 2017-09-01 | 115 | 0 |
| K162449 | Solero MTA System, Solero Microwave Tissue Ablation Applicat | AngioDynamics, Inc. | 2017-05-05 | 246 | 0 |
| K163118 | FLEX Microwave Ablation System and Accessories | Neuwave Medical, Inc. | 2017-03-09 | 121 | 0 |
| K163105 | Emprint Ablation System | Covidien, LLC | 2016-12-06 | 29 | 0 |
| K160141 | miraDry System | Miramar Labs, Inc. | 2016-10-31 | 284 | 0 |
| K160936 | Certus 140 2.45GHz Ablation System | Neuwave Medical, Inc. | 2016-05-04 | 30 | 0 |
| K143203 | AveCure Microwave Coagulation-Ablation Generator, AveCure Mi | Medwaves Incorporated | 2015-08-26 | 292 | 0 |
| K141785 | MICRO THERMX MICROWAVE ABLATION SYSTEM AND ACCESSORIES | Bsd Medical Corp. | 2015-03-31 | 272 | 0 |
| K133821 | EMPRINT ABLATION SYSTEM | Covidien, LLC | 2014-04-28 | 133 | 1 |
| K130399 | CERTUS 140 CERTUSURGGT SURGICAL TOOL | Neuwave Medical, Inc. | 2013-07-18 | 149 | 0 |
| K122217 | CERTUS 140 2.45GHZ ABLATION SYSTEM | Neuwave Medical, Inc. | 2012-12-19 | 147 | 0 |
| K122762 | ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR | Microsulis Medical Limited | 2012-11-30 | 81 | 0 |
| K113237 | CERTUS 140 2.45GHZ ABLATION SYSTEM | Neuwave Medical, Inc. | 2012-01-04 | 63 | 0 |
| K100744 | CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL | Neuwave Medical, Inc. | 2010-10-22 | 220 | 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