Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
GXI — Predicate Candidate Screening
66 FDA 510(k) clearances under this product code; the 50 most recent screened below.
101 daysmedian FDA review time
255 days90th percentile
66clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253907 | Disposable Radiofrequency Cannula | ABBOTT MEDICAL | 2026-04-16 | 132 | 0 |
| K251802 | STAR RF Ablation System | Merit Medical Systems, Inc. | 2026-02-13 | 246 | 0 |
| K251243 | OneRF Trigeminal Nerve Radiofrequency Probes | Neuroone Medical Technologies Corp. | 2025-08-15 | 115 | 0 |
| K242841 | Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) | ABBOTT MEDICAL | 2025-05-27 | 250 | 0 |
| K250213 | OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe | Stryker Instruments | 2025-05-15 | 111 | 0 |
| K241367 | RF Cannula | Shanghai Samedical & Plastic Instruments Co., Ltd. | 2025-01-23 | 254 | 0 |
| K222281 | Intracept Intraosseous Nerve Ablation System | Relievant Medsystems, Inc. | 2022-10-26 | 89 | 1 |
| K213836 | Intracept Intraosseous Nerve Ablation System | Relievant Medsystems, Inc. | 2022-03-11 | 92 | 0 |
| K203066 | COOLIEF Cooled Radiofrequency Kit Advanced | Avanos Medical, Inc. | 2020-12-22 | 74 | 0 |
| K190259 | Vesta RF Cannula | Biomerics | 2020-02-07 | 365 | 0 |
| K191293 | LCCS VC-S RF Cannula | Lccs Products Limited | 2020-01-24 | 255 | 0 |
| K190504 | Intracept Intraosseous Nerve Ablation System (RF Probe), Int | Relievant Medsystems | 2019-05-03 | 63 | 0 |
| K183177 | Nitinol Thermocouple (TCN) Electrode | Boston Scientific Corporation | 2019-03-08 | 112 | 7 |
| K190256 | Rulo Radiofrequency Lesion Probe | Epimed International, Inc. | 2019-03-08 | 29 | 0 |
| K180369 | Intracept Intraosseous Nerve Ablation System (component Intr | Relievant Medsystems | 2018-09-14 | 214 | 0 |
| K170827 | INTRACEPT Intraosseous Nerve Ablation System | Relievant Medsystems | 2017-08-09 | 142 | 0 |
| K170708 | OWL RF INSULATED CANNULAE | Diros Technology, Inc. | 2017-06-27 | 111 | 0 |
| K163461 | Coolief* Cooled RF Probe | Halyard Health, Inc. | 2017-04-13 | 125 | 0 |
| K163236 | COOLIEF Cooled Radiofrequency Kit | Halyard Health, Inc. | 2016-12-16 | 29 | 0 |
| K152642 | LCCS Disposable RF Electrode, LCCS Reusable RF Electrode | Lccs Products Limited | 2016-08-26 | 346 | 0 |
| K153272 | INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrum | Relievant Medsystems | 2016-07-09 | 240 | 0 |
| K150371 | Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannul | Diros Technology, Inc. | 2015-07-30 | 167 | 0 |
| K141586 | OWL CANNULAE | Diros Technology, Inc. | 2014-12-30 | 200 | 0 |
| K123178 | STRYKER VENOM ELECTRODES AND CANNULAE | Stryker Instruments, Instruments Div. | 2013-03-28 | 170 | 0 |
| K121773 | NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE | Biomerics | 2012-09-21 | 95 | 0 |
| K112231 | LCCS INSULATED SPINAL NEEDLE (RF CANNULA) | Lccs Products Limited | 2011-08-19 | 15 | 0 |
| K102566 | OWL CANNULAE | Diros Technology, Inc. | 2011-06-03 | 269 | 0 |
| K110593 | OWL RF PROBES | Diros Technology, Inc. | 2011-05-05 | 64 | 0 |
| K101372 | DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 | Baylis Medical Co., Inc. | 2010-08-10 | 85 | 0 |
| K090608 | MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND | Minta Medical Limited | 2010-06-14 | 465 | 0 |
| K092337 | PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, | Baylis Medical Co., Inc. | 2009-10-16 | 73 | 0 |
| K090955 | SMITH & NEPHEW RF CANNULATE | Smith & Nephew, Inc. | 2009-07-16 | 101 | 0 |
| K080771 | TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC | Top Corp. | 2008-11-10 | 236 | 0 |
| K082012 | COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP | Cosman Medical, Inc. | 2008-10-14 | 91 | 0 |
| K071300 | MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CA | Smith & Nephew, Inc. | 2007-07-20 | 72 | 0 |
| K071745 | BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE | Baylis Medical Co., Inc. | 2007-07-19 | 22 | 0 |
| K062946 | TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL | Top Corp. | 2007-02-15 | 140 | 0 |
| K062937 | TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU | Baylis Medical Co., Inc. | 2007-01-08 | 102 | 1 |
| K063467 | SMITH & NEPHEW RF CANNULAE | Smith & Nephew, Inc. | 2006-11-21 | 28 | 0 |
| K060397 | RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CAN | PAJUNK GmbH Medizintechnologie | 2006-08-31 | 197 | 0 |
| K060799 | COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA | Cosman Medical, Inc. | 2006-05-02 | 39 | 0 |
| K053415 | LESIONPOINT RF CANNULA | Cosman Medical, Inc. | 2006-04-25 | 139 | 0 |
| K053082 | BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6 | Baylis Medical Co., Inc. | 2005-11-30 | 28 | 1 |
| K043442 | STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE | Stryker Instruments | 2005-05-31 | 168 | 0 |
| K050084 | COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMI | Cosman Medical, Inc. | 2005-03-17 | 63 | 2 |
| K042375 | SMK, CX, CXE, RCN | Technomed Europe | 2004-10-26 | 55 | 0 |
| K041021 | RF INTRODUCTION CANNULA | Epimed International, Inc. | 2004-09-16 | 149 | 2 |
| K032406 | STRYKER RF ELECTRODES AND CANNULAE | Stryker Instruments | 2004-04-01 | 241 | 3 |
| K034012 | SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE | Smith & Nephew, Inc. | 2004-03-16 | 83 | 3 |
| K032196 | NBD DISPOSABLE RF CANNULAE | New Business Development, LLC | 2003-10-09 | 83 | 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