Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
GXZ — Predicate Candidate Screening
53 FDA 510(k) clearances under this product code; the 50 most recent screened below.
140 daysmedian FDA review time
414 days90th percentile
53clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241045 | Disposable Subdermal Needle Electrode, Corkscrew | Technomed Europe | 2024-12-11 | 238 | 0 |
| K232581 | Medical Disposable Sterile Needle Electrode | Suzhou Haishen Medical Device Associates Co., Ltd. | 2023-12-04 | 101 | 0 |
| K231691 | Phantom XL Insulated Dilators | TeDan Surgical Innovations, Inc. | 2023-06-29 | 20 | 0 |
| K200984 | Guardian Needle Electrode | Rhythmlink International, LLC | 2020-05-27 | 43 | 0 |
| K192603 | Spes Medica Subdermal Needle Electrodes | Spes Medica Srl | 2019-11-22 | 63 | 0 |
| K190801 | PressOn Electrode Headset | Rhythmlink International, LLC | 2019-07-10 | 103 | 0 |
| K161566 | DMS Disposable Subdermal Needle Electrodes | Daehan Medical Systems Co., Ltd. | 2016-12-21 | 198 | 0 |
| K142470 | E-Shield Multi-paried Subdermal Needle Electrodes | Neuroinvent, Inc. | 2014-11-05 | 63 | 0 |
| K140200 | E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES | Neuroinvent, Inc. | 2014-07-18 | 172 | 0 |
| K130220 | MR CONDITIONAL PRESSON ELECTRODE | Rhythmlink International, LLC | 2013-07-22 | 174 | 0 |
| K130136 | DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSA | Technomed Europe | 2013-07-19 | 182 | 0 |
| K121347 | PRESSON ELECTRODE | Rhythmlink International, LLC | 2012-07-12 | 72 | 1 |
| K103103 | PRESSON ELECTRODE | Persyst Development Corp. | 2011-12-08 | 414 | 0 |
| K110419 | AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS | Stryker Spine | 2011-07-28 | 164 | 0 |
| K100912 | DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISP | Kirwan Surgical Products, Inc. | 2010-08-19 | 140 | 0 |
| K073229 | NERVE MONITORING CABLE | Pioneer Surgical Technology | 2008-06-06 | 204 | 0 |
| K072276 | SUBDERMAL NEEDLE ELECTRODES | Xian Friendship Electronics Co., Ltd. | 2008-05-16 | 275 | 0 |
| K063729 | DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 | Technomed Europe | 2007-08-21 | 249 | 0 |
| K071185 | MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE | Ambu A/S | 2007-05-30 | 30 | 0 |
| K062996 | DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES | Axon Systems, Inc. | 2007-01-12 | 102 | 0 |
| K062880 | SUBDERMAL WIRE ELECTRODE, MODEL SWE | Ives Eeg Solutions, Inc. | 2006-12-22 | 87 | 0 |
| K060189 | PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE) | Ives Eeg Solutions, Inc. | 2006-05-30 | 126 | 0 |
| K052111 | XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, | Excel Tech. , Ltd. | 2005-08-17 | 13 | 0 |
| K050325 | DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPO | Technomed Europe | 2005-05-05 | 85 | 0 |
| K050194 | AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES | Axon Systems, Inc. | 2005-04-26 | 89 | 0 |
| K040639 | ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE | Isurgical | 2004-05-21 | 72 | 0 |
| K023472 | LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-8 | Class A Enterprises, Inc. | 2003-03-18 | 153 | 0 |
| K022914 | RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES | Rhythmlink International, LLC | 2002-12-20 | 108 | 0 |
| K020910 | SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODEL | The Electrode Store, Inc. | 2002-07-19 | 121 | 0 |
| K021118 | DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 61 | Class A Ent. | 2002-05-28 | 50 | 0 |
| K010019 | STERILE SUBDERMAL NEEDLE ELECTRODES | Nicolet Biomedical, Inc. | 2001-03-19 | 76 | 1 |
| K990100 | POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE | Te ME NA S.A.R.L. | 2000-08-02 | 576 | 19 |
| K990793 | ACCUGUIDE MUSCLE INJECTION MONITOR | Medtronic Xomed | 1999-10-22 | 226 | 1 |
| K983597 | NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES | Medicotest, Inc. | 1999-01-11 | 90 | 0 |
| K974119 | DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRO | Jack'S Electrodes | 1998-01-28 | 89 | 0 |
| K950314 | DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19) | Dantec Medical, Inc. | 1996-03-25 | 424 | 0 |
| K926094 | PROTECTRODE SYSTEM | The Electrode Store, Inc. | 1995-12-06 | 1099 | 0 |
| K934779 | AGRAM SPYRAL ELECTRODE | Agram Export-Import Co. | 1995-03-14 | 524 | 0 |
| K933796 | EEG NEEDLE ELECTRODE | Cadwell Laboratories, Inc. | 1994-12-29 | 512 | 0 |
| K933795 | CONCENTRIC EMG NEEDLE ELECTRODE | Cadwell Laboratories, Inc. | 1994-04-22 | 261 | 0 |
| K933806 | MONOPOLAR EMG NEEDLE ELECTRODE | Cadwell Laboratories, Inc. | 1994-04-22 | 261 | 0 |
| K933793 | GROUND/REFERENCE NEEDLE ELECTRODE | Cadwell Laboratories, Inc. | 1994-04-19 | 258 | 0 |
| K926349 | PROBLOC INSULATED NEEDLES | Life-Tech Intl., Inc. | 1993-07-29 | 224 | 0 |
| K920352 | BIO-DETEK EEG ELECTRODE | Bio-Detek, Inc. | 1992-08-14 | 200 | 0 |
| K912783 | DISPOSABLE MONOPOLAR NEEDLE ELECTRODE | Class A Ent. | 1992-02-05 | 226 | 0 |
| K894911 | SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118 | Dantec Electronics, Inc. | 1990-05-14 | 286 | 0 |
| K900740 | SPECIMEX DC | Soredex Medical Systems | 1990-05-11 | 84 | 0 |
| K901280 | DISPOSIBLE EEG NEEDLE ELECTRODES | Medicotest, Inc. | 1990-05-11 | 53 | 0 |
| K896370 | DISP. CONCENTRIC NEEDLE ELECTRODE (DCP-30, DCP-45) | Chalgren Enterprises, Inc. | 1989-12-22 | 46 | 0 |
| K863135 | LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP) | Neurotechnics, Inc. | 1987-09-04 | 385 | 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